Home NDC 67046-0753 CARBAMAZEPINE
Product NDC 67046-0753
11-digit product format 670460753
Labeler code 67046
Product ID 67046-0753_5461d597-8c1a-9ee8-e063-6394a90a737f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Coupler LLC
Application ANDA075712
Marketing category ANDA
Marketing start 2026-06-16
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 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
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.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67046-0753-3 67046075303 30 TABLET, CHEWABLE in 1 BLISTER PACK (67046-0753-3) 2026-06-16 No No Current