Home NDC 69452-312 CARBAMAZEPINE
Product NDC 69452-312
11-digit product format 694520312
Labeler code 69452
Product ID 69452-312_556a28f6-3162-38b6-e063-6294a90a0908
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET
Route ORAL
Labeler Bionpharma Inc.,
Application ANDA218221
Marketing category ANDA
Marketing start 2024-03-15
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 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 A218221-001 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218221-001 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 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 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 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 69452-312-20 CARBAMAZEPINE 100 in 1 BOTTLE TABLET 100 4 69452-312-32 CARBAMAZEPINE 1000 in 1 BOTTLE TABLET 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-312 CARBAMAZEPINE TABLET [BIONPHARMA INC.,] 3 Current NDC, 2 package rows 20250322_138d9ed1-2f8e-d19d-e063-6394a90a695d.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 Sample Exclude flag Status 69452-312-20 69452031220 100 TABLET in 1 BOTTLE (69452-312-20) 100 tablet 2024-03-15 No No Current 69452-312-32 69452031232 1000 TABLET in 1 BOTTLE (69452-312-32) 1000 tablet 2024-07-15 No No Current