Home NDC 51672-4254-6 LAMOTRIGINE
Product NDC 51672-4254
Requested package NDC 51672-4254-6
11-digit product format 516724254
Labeler code 51672
Product ID 51672-4254_5c3ca706-477a-0d5c-e063-6394a90a1c83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamotrigine
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA219677
Marketing category ANDA
Marketing start 2026-03-01
Substance LAMOTRIGINE
Active strength 100 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 A219677-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 A219677-002 LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 A219677-003 LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 A219677-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07
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 A219677-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219677-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219677-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219677-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219677-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219677-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219677-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219677-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219677-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219677-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219677-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219677-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219677-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219677-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219677-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219677-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219677-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219677-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219677-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219677-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2025-10-07 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 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4254-6 LAMOTRIGINE 30 in 1 BOTTLE TABLET 30 7
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 51672-4254-6 51672425406 30 TABLET in 1 BOTTLE (51672-4254-6) 30 tablet 2026-03-01 No No Current