Home NDC 46708-731 CARBAMAZEPINE
Product NDC 46708-731
11-digit product format 467080731
Labeler code 46708
Product ID 46708-731_a742c03d-10b1-48e2-8df1-48967395ae06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA216623
Marketing category ANDA
Marketing start 2024-12-31
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216623-001 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 2025-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216623-001 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 2026-02-19 14:30 UTC 2026-02 A216623-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2025-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216623-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2025-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216623-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2025-04-16 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216623-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2025-04-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216623-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216623-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216623-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216623-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base CARBAMAZEPINE
Listing expiration 2026-12-31 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 46708-731-10 CARBAMAZEPINE 100 in 1 CARTON TABLET 100 1 46708-731-10 CARBAMAZEPINE 10 in 1 BLISTER PACK TABLET 10 1 46708-731-31 CARBAMAZEPINE 100 in 1 BOTTLE TABLET 100 1 46708-731-60 CARBAMAZEPINE 60 in 1 BOTTLE TABLET 60 1 46708-731-91 CARBAMAZEPINE 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-731 CARBAMAZEPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 5 package rows 20250427_a742c03d-10b1-48e2-8df1-48967395ae06.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 · 2 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 46708-731-10 46708073110 100 BLISTER PACK in 1 CARTON (46708-731-10) / 10 TABLET in 1 BLISTER PACK 100 blister pack 2025-04-22 No No Current 46708-731-31 46708073131 100 TABLET in 1 BOTTLE (46708-731-31) 100 tablet 2025-04-22 No No Current 46708-731-60 46708073160 60 TABLET in 1 BOTTLE (46708-731-60) 60 tablet 2025-04-22 No No Current 46708-731-91 46708073191 1000 TABLET in 1 BOTTLE (46708-731-91) 1000 tablet 2025-04-22 No No Current