Home NDC 0093-0778 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0093-0778-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0093-0778-01 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073524-001 EPITOL CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073524-001 AB
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073524-001 EPITOL 100MG TABLET, CHEWABLE / ORAL AB 1992-07-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-0778-01 Carbamazepine 100 in 1 BOTTLE TABLET, CHEWABLE 100 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 ACACIA INACTIVE INGREDIENT 5C5403N26O CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 ETHYLCELLULOSE (100 MPA.S) INACTIVE INGREDIENT 47MLB0F1MV CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC] 16 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 ACACIA INACTIVE INGREDIENT 5C5403N26O CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 ETHYLCELLULOSE (100 MPA.S) INACTIVE INGREDIENT 47MLB0F1MV CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 7 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-0778-01 00093077801 100 TABLET, CHEWABLE in 1 BOTTLE (0093-0778-01) 1995-09-18 0000-00-00 No No Current