Home NDC 70954-240 Carbamazepine
Product NDC 70954-240
11-digit product format 709540240
Labeler code 70954
Product ID 70954-240_cd071fae-afb9-4b46-8e1c-dcb99d5c0f61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA214277
Marketing category ANDA
Marketing start 2022-10-06
Substance CARBAMAZEPINE
Active strength 100 mg/5mL
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 A214277-001 CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214277-001 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 2026-09-14 22:38:34 2026-08 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 a50c72e98297…
Observed Orange Book normalized TE history# 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/5mL
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 308976 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 70954-240-10 Carbamazepine 1 in 1 CARTON SUSPENSION 1 3 70954-240-10 Carbamazepine 450 mL in 1 BOTTLE SUSPENSION 450 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-240 CARBAMAZEPINE SUSPENSION [ANI PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231118_e006049f-1c0c-4544-969e-0344d1b8c5ba.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 · 1 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 70954-240-10 70954024010 1 BOTTLE in 1 CARTON (70954-240-10) / 450 mL in 1 BOTTLE 1 bottle 2022-10-06 0000-00-00 No No Current