Home NDC 46708-420 Carbamazepine
Product NDC 46708-420
11-digit product format 467080420
Labeler code 46708
Product ID 46708-420_1fc170d7-db1a-486d-8c10-faa6e3da3b1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA219939
Marketing category ANDA
Marketing start 2025-07-26
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 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219939-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 A219939-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 A219939-003 CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A219939-001 CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219939-002 CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219939-003 CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219939-001 CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219939-002 CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219939-003 CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219939-001 CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219939-002 CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219939-003 CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219939-001 CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219939-002 CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219939-003 CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2025-07-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Carbamazepine
Listing expiration 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199378 Internal RxNorm lookup 402505 Internal RxNorm lookup 402506 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 46708-420-31 Carbamazepine 100 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 100 1 46708-420-91 Carbamazepine 1000 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 1000 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 46708-420-31 46708042031 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-420-31) 2025-07-26 No No Current 46708-420-91 46708042091 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-420-91) 2025-07-26 No No Current