Home NDC 13668-268 CARBAMAZEPINE
Product NDC 13668-268
11-digit product format 136680268
Labeler code 13668
Product ID 13668-268_2b305f64-7c1a-4cf6-a4ad-57326eb4c874
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA077272
Marketing category ANDA
Marketing start 2009-10-23
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 2026-12-31
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 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 13668-268-01 CARBAMAZEPINE 100 in 1 BOTTLE TABLET 100 22 13668-268-05 CARBAMAZEPINE 500 in 1 BOTTLE TABLET 500 22 13668-268-10 CARBAMAZEPINE 1000 in 1 BOTTLE TABLET 1000 22 13668-268-30 CARBAMAZEPINE 30 in 1 BOTTLE TABLET 30 22 13668-268-31 CARBAMAZEPINE 2500 in 1 BOTTLE TABLET 2500 22
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 CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 9 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-268 CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] 21 Current NDC, Legacy NDC, 5 package rows 20250223_97e6e175-75e8-437b-b457-ddb1ae4e857d.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 13668-268-01 13668026801 100 TABLET in 1 BOTTLE (13668-268-01) 100 tablet 2009-10-23 0000-00-00 No No Current 13668-268-05 13668026805 500 TABLET in 1 BOTTLE (13668-268-05) 500 tablet 2009-10-23 0000-00-00 No No Current 13668-268-10 13668026810 1000 TABLET in 1 BOTTLE (13668-268-10) 1000 tablet 2009-10-23 0000-00-00 No No Current 13668-268-30 13668026830 30 TABLET in 1 BOTTLE (13668-268-30) 30 tablet 2009-10-23 0000-00-00 No No Current 13668-268-31 13668026831 2500 TABLET in 1 BOTTLE (13668-268-31) 2500 tablet 2009-10-23 0000-00-00 No No Current