MANDT |
Client |
MANDT |
|
CLNT |
|
3 |
0 |
|
NDC |
SMX: FDB National Drug Code (NDC) Stored Raw |
ZFDB_NDC |
|
CHAR |
|
11 |
0 |
|
LBLRID |
SMX: FDB Labeler Identifier |
ZFDB_LBLRID |
ZFDB_RLBLRID3
|
CHAR |
|
6 |
0 |
|
GCN_SEQNO |
SMX: FDB GCN - Clinical Formulation ID ( (Stable ID) |
ZFDB_GCN_SEQNO |
ZFDB_RGCNSEQ4
|
CHAR |
|
6 |
0 |
|
PS |
SMX: FDB Package Size |
ZFDB_PS |
|
CHAR |
|
12 |
0 |
|
DF |
SMX: FDB Drug Form Code |
ZFDB_DF |
|
CHAR |
|
1 |
0 |
Possible values
1 |
each (tablets, kits, etc) |
2 |
milliliters (liquids) |
3 |
grams (solids) |
|
AD |
SMX: FDB NDC Additional Descriptor |
ZFDB_AD |
|
CHAR |
|
20 |
0 |
|
LN |
SMX: FDB NDC Label Name |
ZFDB_LN |
|
CHAR |
|
30 |
0 |
|
BN |
SMX: FDB NDC Brand Name |
ZFDB_BN |
|
CHAR |
|
30 |
0 |
|
PNDC |
SMX: FDB Previous National Drug Code |
ZFDB_PNDC |
|
CHAR |
|
11 |
0 |
|
REPNDC |
SMX: FDB Replacement National Drug Code |
ZFDB_REPNDC |
|
CHAR |
|
11 |
0 |
|
NDCFI |
SMX: FDB NDC Format Indicator |
ZFDB_NDCFI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
PIN 5-4-2 (99999-9999-99) -> 5-4-2 (99999999999) |
1 |
NDC - 4-4-2 (9999-9999-99) -> 5-4-2 (09999999999) |
2 |
NDC - 5-3-2 (99999-999-99) -> 5-4-2 (99999099999) |
3 |
NDC - 5-4-1 (99999-9999-9) -> 5-4-2 (99999999909) |
4 |
UPC - 5-5 (99999-99999) -> 5-4-2 (99999099999) |
5 |
UPC - 5-5 (99999-99999) -> 5-4-2 (99999999909) |
6 |
UPC - 5-5 (99999-99999) -> 5-4-2 (99999999990) |
7 |
HRI - 4-6 (9999-999999) -> 5-4-2 (09999999999) |
|
DADDNC |
SMX: FDB NDC Date of Add |
ZFDB_DADDNC |
|
DATS |
|
8 |
0 |
|
DUPDC |
SMX: FDB NDC Date of Update |
ZFDB_DUPDC |
|
DATS |
|
8 |
0 |
|
DESI |
SMX: FDB FDA DESI Drug Indicator |
ZFDB_DESI |
|
CHAR |
|
1 |
0 |
Possible values
NULL |
Product never declared DESI |
0 |
DESI at one point in time, but no longer |
1 |
DESI |
|
DESDTEC |
SMX: FDB DESI Status Change Effective Date |
ZFDB_DESDTEC |
|
DATS |
|
8 |
0 |
|
DESI2 |
SMX: FDB FDA DESI2 Drug Indicator |
ZFDB_DESI2 |
|
CHAR |
|
1 |
0 |
Possible values
NULL |
Product never declared DESI2 |
0 |
DESI2 at one point in time, but no longer |
1 |
DESI2 as specified in the HCFA 1990 Appended list |
|
DES2DTEC |
SMX: FDB DESI2 Status Change Effective Date |
ZFDB_DES2DTEC |
|
DATS |
|
8 |
0 |
|
DEA |
SMX: FDB Drug Enforcement Administration Code |
ZFDB_DEA |
|
CHAR |
|
1 |
0 |
Possible values
0 |
No control |
1 |
LSD, Heroin, Marijuana - Research only |
2 |
Morphine, Meperidine, Amphetamines, etc., most potential for |
3 |
Aspirin/Codeine, etc., less abused |
4 |
Diazepam, etc., potential abuse |
5 |
Controlled sale by pharmacy only |
|
CL |
SMX: FDB Drug Class |
ZFDB_CL |
|
CHAR |
|
1 |
0 |
Possible values
O |
Over-the-counter. Prescription not req'd per product label |
F |
Prescription required per the product labeling |
|
GPI |
Dummy function in length 1 |
DUMMY |
|
CHAR |
|
1 |
0 |
|
HOSP |
SMX: FDB Hospital Selection Indicator |
ZFDB_HOSP |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Not on hospital subset |
1 |
On hospital subset |
|
INNOV |
SMX: FDB Innovator Indicator |
ZFDB_INNOV |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Default�non-innovator drug |
1 |
Innovator |
|
IPI |
SMX: FDB Institutional Product Indicator |
ZFDB_IPI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Not Institutional |
1 |
Institutional |
|
MINI |
SMX: FDB Mini Selection Indicator |
ZFDB_MINI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Not on MINI subset |
1 |
On MINI subset |
|
MAINT |
SMX: FDB Maintenance Drug Indicator |
ZFDB_MAINT |
|
CHAR |
|
1 |
0 |
Possible values
NULL |
Not a maintenance drug |
1 |
Maintenance drug |
|
OBC |
SMX: FDB Orange Book Code (2-Char) |
ZFDB_OBC |
|
CHAR |
|
2 |
0 |
Possible values
AA |
Products with no known bioequivalence problems in convention |
AB |
Products meeting necessary bioequivalence requirements. |
AN |
Solutions and powders for aerosolization that are marketed f |
AO |
Injectable oils with identical active ingredients, concentra |
AP |
Injectable aqueous solutions including dry powders, concentr |
AT |
Topical products therapeutically equivalent in same dosage f |
B |
Products with A or B codes previously assigned; new informat |
BC |
Controlled-release tablets, controlled-release capsules, and |
BD |
Active ingredients and dosage forms with documented bioequiv |
BE |
Enteric coated dosage forms unless proven otherwise to be eq |
BN |
Products in aerosol-nebulizer drug delivery systems that are |
BP |
Active ingredients and dosage forms with potential bioequiva |
BR |
Suppositories or enemas for systemic use unless proven to be |
BS |
Products having drug standard deficiencies. |
BT |
Topical products with bioequivalence problems. |
BX |
Insufficient data to determine therapeutic equivalence. |
ZA |
Particular pharmaceutical entity (GCN) looked at but particu |
ZB |
Particular pharmaceutical entity was not evaluated. |
ZC |
Pharmaceutical entity and labeler evaluated but no therapeut |
|
OBSDTEC |
SMX: FDB Obsolete Date |
ZFDB_OBSDTEC |
|
DATS |
|
8 |
0 |
|
PPI |
SMX: FDB Patient Package Insert Indicator |
ZFDB_PPI |
|
CHAR |
|
1 |
0 |
Possible values
NULL |
Not required |
1 |
Patient Package Insert Required |
|
STPK |
SMX: FDB Standard Package Indicator |
ZFDB_STPK |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Standard package |
1 |
All Other Package Sizes |
|
REPACK |
SMX: FDB Repackaged Indicator |
ZFDB_REPACK |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Not repackaged |
1 |
Repackaged |
|
TOP200 |
SMX: FDB Top 200 Drugs Indicator |
ZFDB_TOP200 |
|
CHAR |
|
3 |
0 |
Possible values
000 |
All Other Drugs |
001 |
Top 200 Drugs in order of rank |
|
UD |
SMX: FDB Unit Dose Indicator |
ZFDB_UD |
|
CHAR |
|
1 |
0 |
Possible values
0 |
All Other Products |
1 |
Unit Dose |
|
CSP |
SMX: FDB Case Pack |
ZFDB_CSP |
|
CHAR |
|
7 |
0 |
|
NDL_GDGE |
SMX: FDB Needle Gauge |
ZFDB_NDL_GDGE |
|
CHAR |
|
6 |
0 |
|
NDL_LNGTH |
SMX: FDB Needle Length |
ZFDB_NDL_LNGTH |
|
CHAR |
|
6 |
0 |
|
SYR_CPCTY |
SMX: FDB Syringe Capacity (ml) |
ZFDB_SYR_CPCTY |
|
CHAR |
|
6 |
0 |
|
SHLF_PCK |
SMX: FDB Shelf Pack |
ZFDB_SHLF_PCK |
|
CHAR |
|
7 |
0 |
|
SHIPPER |
SMX: FDB Shipper Quantity |
ZFDB_SHIPPER |
|
CHAR |
|
7 |
0 |
|
HCFA_FDA |
HCFA FDA Therapeutic Equivalency Code (aka Orange Book Code) |
ZFDB_HCFA_FDA |
|
CHAR |
|
2 |
0 |
Possible values
AA |
Products with no known bioequivalence problems in convention |
AB |
Products meeting necessary bioequivalence requirements. |
AN |
Solutions and powders for aerosolization that are marketed f |
AO |
Injectable oils with identical active ingredients, concentra |
AP |
Injectable aqueous solutions including dry powders, concentr |
AT |
Topical products therapeutically equivalent in same dosage f |
B |
Products with A or B codes previously assigned; new informat |
BC |
Controlled-release tablets, controlled-release capsules, and |
BD |
Active ingredients and dosage forms with documented bioequiv |
BE |
Enteric coated dosage forms unless proven otherwise to be eq |
BN |
Products in aerosol-nebulizer drug delivery systems that are |
BP |
Active ingredients and dosage forms with potential bioequiva |
BR |
Suppositories or enemas for systemic use unless proven to be |
BS |
Products having drug standard deficiencies. |
BT |
Topical products with bioequivalence problems. |
BX |
Insufficient data to determine therapeutic equivalence. |
NR |
Not Rated by the Orange Book |
|
HCFA_UNIT |
SMX: FDB HCFA Unit Type Indicator |
ZFDB_HCFA_UNIT |
|
CHAR |
|
3 |
0 |
Possible values
AHF |
Antihemophilic Factor |
CAP |
Capsule |
EA |
Each |
GM |
Gram |
ML |
Milliliter |
SUP |
Suppository |
TAB |
Tablet |
TDP |
Transdermal Patch |
|
HCFA_PS |
SMX: FDB HCFA Units Per Package Size |
ZFDB_HCFA_PS |
|
CHAR |
|
12 |
0 |
|
HCFA_APPC |
SMX: FDB HCFA Approval Date |
ZFDB_HCFA_APPC |
|
DATS |
|
8 |
0 |
|
HCFA_MRKC |
SMX: FDB HCFA Market Entry Date |
ZFDB_HCFA_MRKC |
|
DATS |
|
8 |
0 |
|
HCFA_TRMC |
SMX: FDB HCFA Termination Date |
ZFDB_HCFA_TRMC |
|
DATS |
|
8 |
0 |
|
HCFA_TYP |
SMX: FDB HCFA Drug Type Indicator |
ZFDB_HCFA_TYP |
|
CHAR |
|
1 |
0 |
Possible values
NULL |
Not provided by HCFA |
1 |
Designated by the FDA as prescription only |
2 |
Over the Counter |
|
HCFA_DESC1 |
HCFA DESI Effective Date |
ZFDB_HCFA_DESC1 |
|
DATS |
|
8 |
0 |
|
HCFA_DESI1 |
SMX: FDB HCFA DESI Code |
ZFDB_HCFA_DESI1 |
|
CHAR |
|
1 |
0 |
Possible values
0 |
NDC not on HCFA tape (no information submitted by manufactur |
2 |
Safe and Effective or non-DESI |
3 |
DESI/IRS Drugs Under Review (No NOOH issued) |
4 |
Less than effective DESI/IRS Drugs for Some Indications |
5 |
Less than effective DESI/IRS Drugs for All Indications |
6 |
Less than effective DESI/IRS Drugs Removed from the Market |
|
UU |
SMX: FDB Unit of Use Indicator |
ZFDB_UU |
|
CHAR |
|
1 |
0 |
Possible values
0 |
All Other Products |
1 |
Unit of Use |
|
PD |
SMX: FDB Package Description |
ZFDB_PD |
|
CHAR |
|
10 |
0 |
Possible values
AER BR.ACT |
Aerosol, Breath Activated |
AER REF |
Aerosol, Refill Unit |
AER W/ADAP |
Aerosol with Adapter |
AMP W/DEV |
Ampul with Device |
AMPUL |
Ampul |
AMPUL/KIT |
Ampul/Kit |
BAG |
Bag |
BLIST PACK |
Blister Pack |
BOTTLE |
Bottle |
BOX |
Box |
CAN |
Can |
CANISTER |
Canister |
CANIT RFU |
Canister, Refill Unit |
CARTRIDGE |
Cartridge |
CUP |
Cup |
**DISPENSE |
Dispenser |
DOSE-PACK |
Dispensing Pack |
DROP BTL |
Dropper Bottle |
DRUM |
Drum |
FLEX CONT |
Flexible Container |
GLASS CONT |
Glass Container |
JAR |
Jar |
KIT |
Kit |
KIT-REFILL |
Kit-Refill |
**N/A |
Not Applicable |
**PACKAGE |
Package |
PACKET |
Packet |
PF APPLI |
Applicator, Pre-filled |
ROLL |
Roll |
**SOLN BTL |
Solution Bottle |
SQUEEZ BTL |
Squeeze Bottle |
SYRINGE |
Syringe |
**TINE |
Tine |
TUBE |
Tube |
TUBE STICK |
Tube Stick |
**TUBE/JAR |
Tube/Jar |
TUBE/KIT |
Tube/Kit |
VIAL |
Vial |
VIAL/KIT |
Vial/Kit |
|
LN25 |
SMX: FDB Label Name - 25 Characters |
ZFDB_LN25 |
|
CHAR |
|
25 |
0 |
|
LN25I |
SMX: FDB Label Name - 25 Generic Name Use Indicator |
ZFDB_LN25I |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Brand name abbreviation up to 12 bytes within LN25 |
1 |
Generic name abbreviation up to 12 bytes within LN25 |
|
GPIDC |
Dummy function in length 1 |
DUMMY |
|
CHAR |
|
1 |
0 |
|
BBDC |
Dummy function in length 1 |
DUMMY |
|
CHAR |
|
1 |
0 |
|
HOME |
SMX: FDB Home Health Indicator |
ZFDB_HOME |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Not on HOME subset |
1 |
On HOME subset |
|
INPCKI |
SMX: FDB Inner Package Indicator |
ZFDB_INPCKI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
All Others |
1 |
Inner Package |
|
OUTPCKI |
SMX: FDB Outer Package Indicator |
ZFDB_OUTPCKI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
All Others |
1 |
Outer Package |
|
OBC_EXP |
SMX: FDB Expanded Orange Book Code |
ZFDB_OBC_EXP |
|
CHAR |
|
2 |
0 |
Possible values
AA |
Products with no known bioequivalence problems in conv. form |
AB |
Products meeting necessary bioequivalence requirements. |
AN |
Solutions and powders for aerosolization that are marketed.. |
AO |
Injectable oils with identical active ingredients, concentra |
AP |
Injectable aqueous solutions including dry powders, concentr |
AT |
Topical products therapeutically equivalent in same dosage f |
B |
Products with A or B codes previously assigned; new informat |
BC |
Controlled-release tablets, controlled-release capsules, and |
BD |
Active ingredients and dosage forms with documented bioequiv |
BE |
Enteric coated dosage forms unless proven otherwise to be eq |
BN |
Products in aerosol-nebulizer drug delivery systems that are |
BP |
Active ingredients and dosage forms with potential bioequiva |
BR |
Suppositories or enemas for systemic use unless proven to be |
BS |
Products having drug standard deficiencies. |
BT |
Topical products with bioequivalence problems. |
BX |
Insufficient data to determine therapeutic equivalence. |
ZA |
Particular pharmaceutical entity (GCN) looked at but particu |
ZB |
Particular pharmaceutical entity was not evaluated. |
ZC |
Pharmaceutical entity and labeler evaluated but no therapeut |
|
PS_EQUIV |
SMX: FDB Package Size Equivalent Value |
ZFDB_PS_EQUIV |
|
CHAR |
|
12 |
0 |
|
PLBLR |
SMX: FDB Private Labeler Indicator |
ZFDB_PLBLR |
|
CHAR |
|
1 |
0 |
Possible values
0 |
All Others |
1 |
Private Labeler |
|
TOP50GEN |
SMX: FDB Top 50 Generics |
ZFDB_TOP50GEN |
|
CHAR |
|
2 |
0 |
Possible values
0 |
Not in the top 50 |
00 |
Not in the top 50 |
01 |
Ranking within the top 50 |
|
OBC3 |
SMX: FDB Orange Book Code; 3-Byte Version |
ZFDB_OBC3 |
|
CHAR |
|
3 |
0 |
Possible values
AA |
Products with no known bioequivalence problems in convention |
AB |
Products meeting necessary bioequivalence requirements. |
AB1 |
Products meeting necessary bioequivalence requirements. |
AB2 |
Products meeting necessary bioequivalence requirements. |
AB3 |
Products meeting necessary bioequivalence requirements. |
AN |
Solutions and powders for aerosolization |
AO |
Injectable oils with identical active ingredients, concentra |
AP |
Injectable aqueous solutions including dry powders, concentr |
AT |
Topical products therapeutically equivalent in same dosage f |
B |
Products with A or B codes previously assigned; new informat |
BC |
Controlled-release tablets, controlled-release capsules, and |
BD |
Active ingredients and dosage forms with documented bioequiv |
BE |
Enteric coated dosage forms unless proven otherwise to be eq |
BN |
Products in aerosol-nebulizer drug delivery systems that are |
BP |
Active ingredients and dosage forms with potential bioequiva |
BR |
Suppositories or enemas for systemic use unless proven to be |
BS |
Products having drug standard deficiencies. |
BT |
Topical products with bioequivalence problems. |
BX |
Insufficient data to determine therapeutic equivalence. |
ZA |
Particular pharmaceutical entity (GCN) looked at but particu |
ZB |
Particular pharmaceutical entity was not evaluated. |
ZC |
Pharmaceutical entity and labeler evaluated but no therapeut |
|
GMI |
SMX: FDB Generic Manufacturer Indicator |
ZFDB_GMI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Non-drug item, such as medical supplies and bulk chemicals |
1 |
Generic manufacturer |
2 |
Brand manufacturer |
3 |
Alternative (niche) manufacturer (no longer being applied) |
4 |
Indeterminate (Labelers that are not otherwise classified) |
|
GNI |
SMX: FDB Generic Name Indicator |
ZFDB_GNI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Non-drug item, such as medical supplies and bulk chemicals |
1 |
Generically named |
2 |
Brand named |
|
GSI |
Dummy function in length 1 |
DUMMY |
|
CHAR |
|
1 |
0 |
|
GTI |
SMX: FDB Therapeutic Equivalence Indicator |
ZFDB_GTI |
|
CHAR |
|
1 |
0 |
Possible values
0 |
Non-drug item, such as medical supplies and bulk chemicals |
1 |
Orange Book B-rated drug product |
2 |
Single source |
3 |
Orange Book A-rated drug product |
4 |
Product not listed in the Orange Book |
|
NDCGI1 |
SMX: FDB Multi-Source/Single Source Indicator |
ZFBD_NDCGI1 |
|
CHAR |
|
1 |
0 |
Possible values
1 |
Multiple source |
2 |
Single source |
|
HCFA_DC |
SMX: FDB HCFA Drug Category |
ZFDB_HCFA_DC |
|
CHAR |
|
1 |
0 |
Possible values
NULL |
Unspecified |
S |
Single Source |
I |
Innovator Multi-source |
N |
Non-Innovator Multi-source |
|
LN60 |
SMX: FDB Label Name - 60 Characters |
ZFDB_LN60 |
|
CHAR |
|
60 |
0 |
|