FDA.reportPublic FDA data

Carbamazepine

Product NDC
0093-0109
11-digit product format
000930109
Labeler code
0093
Product ID
0093-0109_042aa2c6-95ff-410a-abcf-a8ee79fa96d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA070541
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
2026-07-31
Substance
CARBAMAZEPINE
Active strength
200 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308973, 308979

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
0093-0109-01Carbamazepine100 in 1 BOTTLETABLET10028
0093-0109-10Carbamazepine1000 in 1 BOTTLETABLET100028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0109-01EA - Each0093-01091b6c8e15-dc2b-4ae9-92de-bb904c40039112012-07-24
0093-0109-10EA - Each0093-01096cd8954d-9b9c-4314-bab5-d33413016e6a12012-07-24

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 INGREDIENT33CM23913MCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
ACACIAINACTIVE INGREDIENT5C5403N26OCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]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
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [STAT RX USA LLC]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [STAT RX USA LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [STAT RX USA LLC]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET [STAT RX USA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSNebcffad6-da03-43f4-a75b-7de13e94bb7d103
308979carbamazepine 200 MG Oral TabletSCDebcffad6-da03-43f4-a75b-7de13e94bb7d103
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 TabletPSN25cca2b1-9020-4d8a-bc22-b8063e57f9e12
308979carBAMazepine 200 MG Oral TabletPSNf38feadf-3fa4-430c-99ed-374023f8132c2
308973carbamazepine 100 MG Chewable TabletSCDf38feadf-3fa4-430c-99ed-374023f8132c2
308979carbamazepine 200 MG Oral TabletSCD25cca2b1-9020-4d8a-bc22-b8063e57f9e12
308979carbamazepine 200 MG Oral TabletSCDf38feadf-3fa4-430c-99ed-374023f8132c2
308979carBAMazepine 200 MG Oral TabletPSN8e06995c-26c9-4ef3-9421-16a2360db6281
308979carBAMazepine 200 MG Oral TabletPSN988cce8b-eb9f-4bf7-85bc-a736575d98b11
308979carbamazepine 200 MG Oral TabletSCD8e06995c-26c9-4ef3-9421-16a2360db6281
308979carbamazepine 200 MG Oral TabletSCD988cce8b-eb9f-4bf7-85bc-a736575d98b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0109-0100093010901100 TABLET in 1 BOTTLE (0093-0109-01) 100 tablet1990-09-302026-06-30NoNoCurrent
0093-0109-10000930109101000 TABLET in 1 BOTTLE (0093-0109-10) 1000 tablet1990-09-302026-07-31NoNoCurrent