Home NDC 0904-3854 CARBAMAZEPINE
Product NDC 0904-3854
11-digit product format 009043854
Labeler code 0904
Product ID 0904-3854_8c5d19ef-ad54-44a0-afdf-632120c5446c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA075712
Marketing category ANDA
Marketing start 2010-03-22
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 2027-12-31
Current FDA listing Yes 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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075712-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075712-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CARBAMAZEPINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-3854-61 CARBAMAZEPINE 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 27 0904-3854-61 CARBAMAZEPINE 100 in 1 CARTON TABLET, CHEWABLE 100 27 0904-3854-80 CARBAMAZEPINE 1000 in 1 BOTTLE TABLET, CHEWABLE 1000 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-3854 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET [MAJOR PHARMACEUTICALS] 24 Current NDC, Legacy NDC, 3 package rows 20250507_2a8c7366-ce89-47ce-8123-96f26812fca0.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-3854-61 00904385461 100 BLISTER PACK in 1 CARTON (0904-3854-61) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 100 blister pack 2010-03-22 0000-00-00 No No Current 0904-3854-80 00904385480 1000 TABLET, CHEWABLE in 1 BOTTLE (0904-3854-80) 2010-03-22 0000-00-00 No No Current