Home NDC 72162-2572 CARBAMAZEPINE
Product NDC 72162-2572
11-digit product format 721622572
Labeler code 72162
Product ID 72162-2572_c6050a23-3446-423e-94da-0054ef635aa8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075712
Marketing category ANDA
Marketing start 2009-08-26
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 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…2022-10-28 04:53 UTC 2022-10 A075712-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2001-07-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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
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 308973 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 72162-2572-1 CARBAMAZEPINE 100 in 1 BOTTLE TABLET, CHEWABLE 100 101 72162-2572-5 CARBAMAZEPINE 500 in 1 BOTTLE TABLET, CHEWABLE 500 101
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CARBAMAZEPINE CARBAMAZEPINE Torrent Pharmaceuticals Limited 97e6e175-75e8-437b-b457-ddb1ae4e857d 2026-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075712 application number: ANDA075712 CARBAMAZEPINE CARBAMAZEPINE Coupler LLC 5461e739-0f18-b012-e063-6394a90a6b14 2026-06-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075712 application number: ANDA075712 CARBAMAZEPINE CARBAMAZEPINE Bryant Ranch Prepack c72a0668-7cd7-46a8-86d1-d3c17c4b900f 2026-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075712 application number: ANDA075712 ndc (product): 72162-2572 Carbamazepine CARBAMAZEPINE American Health Packaging f8444c23-a74f-4d44-867e-26554dbb882f 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075712 application number: ANDA075712
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-2572-1 72162257201 100 TABLET, CHEWABLE in 1 BOTTLE (72162-2572-1) 2025-11-17 No No Current 72162-2572-5 72162257205 500 TABLET, CHEWABLE in 1 BOTTLE (72162-2572-5) 2025-11-17 No No Current