Home NDC 68071-3988-6 Carbamazepine
Product NDC 68071-3988
Requested package NDC 68071-3988-6
11-digit product format 680713988
Labeler code 68071
Product ID 68071-3988_509bd366-ebec-ee9b-e063-6294a90ab7ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA213284
Marketing category ANDA
Marketing start 2022-11-01
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213284-001 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213284-001 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.
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 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213284-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2022-08-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68071-3988-6 Carbamazepine 60 in 1 BOTTLE TABLET 60 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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE REMEDYREPACK INC. 8cc7288c-4a7e-417c-9ceb-0e0f8aeeacb3 2026-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213284 application number: ANDA213284 Carbamazepine CARBAMAZEPINE NuCare Pharmaceuticals, Inc. 509bd024-9944-a2f3-e063-6394a90ae4cb 2026-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213284 application number: ANDA213284 ndc (package): 68071-3988-6 ndc (product): 68071-3988 ndc11 (package): 68071398806 Carbamazepine CARBAMAZEPINE Unichem Pharmaceuticals (USA), Inc. 50ba2042-fc67-4266-a773-a30f07649a5a 2023-10-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213284 application number: ANDA213284
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3988-6 68071398806 60 TABLET in 1 BOTTLE (68071-3988-6) 60 tablet 2026-04-29 No No Current