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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-0109DDiscontinued by firm2026-08-17
excluded packagepackage0093-01090093-0109-01DDiscontinued by firm2026-08-17
excluded packagepackage0093-01090093-0109-10DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070541-001EPITOLCARBAMAZEPINE200MGTABLET / ORALAB1986-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A070541-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070541-001EPITOL200MGTABLET / ORALAB1986-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070541-001EPITOL200MGTABLET / ORALAB1986-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A070541-001EPITOL200MGTABLET / ORALAB1986-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070541-001EPITOL200MGTABLET / ORALAB1986-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070541-001EPITOL200MGTABLET / ORALAB1986-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070541-001EPITOL200MGTABLET / ORALAB1986-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070541-001EPITOL200MGTABLET / ORALAB1986-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070541-001EPITOL200MGTABLET / ORALAB1986-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070541-001EPITOL200MGTABLET / ORALAB1986-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070541-001EPITOL200MGTABLET / ORALAB1986-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070541-001EPITOL200MGTABLET / ORALAB1986-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070541-001EPITOL200MGTABLET / ORALAB1986-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070541-001EPITOL200MGTABLET / ORALAB1986-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070541-001EPITOL200MGTABLET / ORALAB1986-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070541-001EPITOL200MGTABLET / ORALAB1986-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070541-001EPITOL200MGTABLET / ORALAB1986-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070541-001EPITOL200MGTABLET / ORALAB1986-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070541-001EPITOL200MGTABLET / ORALAB1986-09-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A070541-001EPITOL200MGTABLET / ORALAB1986-09-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070541-001EPITOL200MGTABLET / ORALAB1986-09-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A070541-001EPITOL200MGTABLET / ORALAB1986-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A070541-001EPITOL200MGTABLET / ORALAB1986-09-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070541-001EPITOL200MGTABLET / ORALAB1986-09-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070541-001EPITOL200MGTABLET / ORALAB1986-09-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070541-001EPITOL200MGTABLET / ORALAB1986-09-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070541-001EPITOL200MGTABLET / ORALAB1986-09-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070541-001EPITOL200MGTABLET / ORALAB1986-09-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070541-001EPITOL200MGTABLET / ORALAB1986-09-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070541-001EPITOL200MGTABLET / ORALAB1986-09-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A070541-001EPITOL200MGTABLET / ORALAB1986-09-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A070541-001EPITOL200MGTABLET / ORALAB1986-09-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070541-001EPITOL200MGTABLET / ORALAB1986-09-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070541-001EPITOL200MGTABLET / ORALAB1986-09-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070541-001EPITOL200MGTABLET / ORALAB1986-09-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070541-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070541-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070541-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070541-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070541-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070541-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070541-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070541-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070541-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070541-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070541-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070541-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070541-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070541-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070541-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070541-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070541-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070541-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070541-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070541-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070541-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070541-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070541-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070541-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070541-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070541-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070541-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070541-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070541-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070541-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070541-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070541-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070541-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070541-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070541-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070541-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070541-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070541-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070541-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070541-001AB1e64feba35796…

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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
ACACIAINACTIVE INGREDIENT5C5403N26OCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.]7
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 [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [STAT RX USA LLC]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackebcffad6-da03-43f4-a75b-7de13e94bb7d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070541
application number: ANDA070541

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