Home NDC 10370-208 Lamotrigine
Product NDC 10370-208
11-digit product format 103700208
Labeler code 10370
Product ID 10370-208_4e8e57a4-ecd3-4fce-943c-1ad74ea1ecc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamotrigine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Par Health USA, LLC
Application ANDA201374
Marketing category ANDA
Marketing start 2026-01-02
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201374-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 A201374-002 LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 A201374-003 LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 A201374-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 A201374-005 LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 A201374-006 LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 A201374-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A201374-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A201374-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A201374-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A201374-005 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A201374-006 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2012-12-26 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Lamotrigine
Brand name suffix Extended-Release
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 850087 Internal RxNorm lookup 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 10370-208-11 LamotrigineExtended-Release 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 7
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 10370-208-11 10370020811 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-208-11) 2026-01-02 No No Current