Home NDC 46708-418 Lamotrigine
Product NDC 46708-418
11-digit product format 467080418
Labeler code 46708
Product ID 46708-418_faee013c-cad2-4abb-904c-e6ff79ba778c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA211821
Marketing category ANDA
Marketing start 2024-10-07
Substance LAMOTRIGINE
Active strength 250 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
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 A211821-001 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 A211821-002 LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 A211821-003 LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01
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 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211821-001 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211821-002 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211821-003 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-10-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lamotrigine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMOTRIGINE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3H27498KS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 900156 Internal RxNorm lookup 1098608 Internal RxNorm lookup 1146690 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 46708-418-30 Lamotrigine 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 1 46708-418-91 Lamotrigine 1000 in 1 BOTTLE TABLET, EXTENDED RELEASE 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-418 LAMOTRIGINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20241013_faee013c-cad2-4abb-904c-e6ff79ba778c.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 Marketing start Sample Exclude flag Status 46708-418-30 46708041830 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-30) 2024-10-07 No No Current 46708-418-91 46708041891 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-91) 2024-10-07 No No Current