FDA.reportPublic FDA data

Carbamazepine

Product NDC
0093-0778
11-digit product format
000930778
Labeler code
0093
Product ID
0093-0778_58b00f0d-faf9-43ee-8142-52bcb004fed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA073524
Marketing category
ANDA
Marketing start
1995-09-18
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-0778-01Carbamazepine100 in 1 BOTTLETABLET, CHEWABLE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0778-01EA - Each0093-07783eadbe2e-0bb4-4a7b-b0d0-a1828a8dfb2a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ACACIAINACTIVE INGREDIENT5C5403N26OCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSNbfd63965-56e6-4af7-b7ef-45a5105d4d3528
308979carBAMazepine 200 MG Oral TabletPSNbfd63965-56e6-4af7-b7ef-45a5105d4d3528
308973carbamazepine 100 MG Chewable TabletSCDbfd63965-56e6-4af7-b7ef-45a5105d4d3528
308979carbamazepine 200 MG Oral TabletSCDbfd63965-56e6-4af7-b7ef-45a5105d4d3528
308973carBAMazepine 100 MG Chewable TabletPSNf38feadf-3fa4-430c-99ed-374023f8132c2
308979carBAMazepine 200 MG Oral TabletPSNf38feadf-3fa4-430c-99ed-374023f8132c2
308973carbamazepine 100 MG Chewable TabletSCDf38feadf-3fa4-430c-99ed-374023f8132c2
308979carbamazepine 200 MG Oral TabletSCDf38feadf-3fa4-430c-99ed-374023f8132c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-0778-0100093077801100 TABLET, CHEWABLE in 1 BOTTLE (0093-0778-01) 1995-09-180000-00-00NoNoCurrent