Home NDC 46708-771-15 Lamotrigine
Product NDC 46708-771
Requested package NDC 46708-771-15
11-digit product format 467080771
Labeler code 46708
Product ID 46708-771_03610cdf-7eaa-445c-a441-ff17be5a7c68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA217278
Marketing category ANDA
Marketing start 2026-03-02
Substance LAMOTRIGINE
Active strength 50 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 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217278-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 A217278-002 LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 A217278-003 LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 A217278-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-09-14 22:38:34 2026-08 A217278-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217278-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217278-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217278-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217278-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217278-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217278-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217278-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217278-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217278-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217278-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217278-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-02-25 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 Lamotrigine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMOTRIGINE 50 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103968 Internal RxNorm lookup 198430 Internal RxNorm lookup 252478 Internal RxNorm lookup 252479 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 46708-771-15 Lamotrigine 2 in 1 CARTON TABLET, ORALLY DISINTEGRATING 2 1 46708-771-15 Lamotrigine 15 in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING 15 1 46708-771-30 Lamotrigine 30 in 1 BOTTLE TABLET, ORALLY DISINTEGRATING 30 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 Units Marketing start Sample Exclude flag Status 46708-771-15 46708077115 2 BLISTER PACK in 1 CARTON (46708-771-15) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2 blister pack 2026-03-02 No No Current