Home NDC 42291-369-50 Lamotrigine
Product NDC 42291-369
Requested package NDC 42291-369-50
11-digit product format 422910369
Labeler code 42291
Product ID 42291-369_51b57ded-2d7d-d540-e063-6394a90a4744
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA079132
Marketing category ANDA
Marketing start 2013-04-10
Substance LAMOTRIGINE
Active strength 200 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 1 .
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 A079132-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 A079132-002 LAMOTRIGINE LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 A079132-003 LAMOTRIGINE LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 A079132-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27
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 2026-08-01 22:54:32 2026-06 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Lamotrigine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMOTRIGINE 200 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 198427 Internal RxNorm lookup 198428 Internal RxNorm lookup 198429 Internal RxNorm lookup 282401 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 42291-369-50 Lamotrigine 500 in 1 BOTTLE TABLET 500 17 42291-369-60 Lamotrigine 60 in 1 BOTTLE TABLET 60 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMOTRIGINE ACTIVE INGREDIENT U3H27498KS LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 LAMOTRIGINE ACTIVE MOIETY U3H27498KS LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-369 LAMOTRIGINE TABLET [AVKARE] 15 Current NDC, Legacy NDC, 2 package rows 20220114_fcdb94a8-33be-6375-98ef-6933999d157f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-369-50 42291036950 500 TABLET in 1 BOTTLE (42291-369-50) 500 tablet 2015-01-28 0000-00-00 No No Current