Home NDC 0904-6172 CARBAMAZEPINE
Product NDC 0904-6172
11-digit product format 009046172
Labeler code 0904
Product ID 0904-6172_4da43d38-dcd6-4447-8693-5e41e78aacbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA077272
Marketing category ANDA
Marketing start 2010-09-20
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
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077272-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 A077272-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 A077272-003 CARBAMAZEPINE CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 A077272-004 CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077272-002 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 5 · 164 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 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL 2005-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2005-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2005-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2005-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077272-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2005-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077272-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2005-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077272-003 CARBAMAZEPINE 300MG TABLET / ORAL 2005-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077272-004 CARBAMAZEPINE 400MG TABLET / ORAL 2005-12-07 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 71 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CARBAMAZEPINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33CM23913M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308973 Internal RxNorm lookup 308979 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-6172-50 CARBAMAZEPINE 2000 in 1 BOTTLE TABLET 2000 27 0904-6172-61 CARBAMAZEPINE 1 in 1 BLISTER PACK TABLET 1 27 0904-6172-61 CARBAMAZEPINE 100 in 1 CARTON TABLET 100 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 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET [CARDINAL HEALTH] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6172 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 0904-6172-50 00904617250 2000 TABLET in 1 BOTTLE (0904-6172-50) 2000 tablet 2010-09-20 0000-00-00 No No Current 0904-6172-61 00904617261 100 BLISTER PACK in 1 CARTON (0904-6172-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2010-09-20 0000-00-00 No No Current