Home NDC 0228-1580 Lamotrigine
Product NDC 0228-1580
11-digit product format 002281580
Labeler code 0228
Product ID 0228-1580_49ac5dcd-9ccd-4e5a-9fdd-fe22a79c2770
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA200672
Marketing category ANDA
Marketing start 2016-04-01
Substance LAMOTRIGINE
Active strength 300 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 44 .
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 A200672-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 A200672-002 LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 A200672-003 LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 A200672-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 A200672-005 LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 A200672-006 LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13
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.
Product history page 1 of 7 · 256 observed 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 2026-10-15 13:18:30 2026-09 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200672-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200672-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200672-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200672-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200672-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200672-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200672-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200672-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200672-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200672-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200672-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200672-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2013-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200672-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200672-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200672-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200672-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-10-17 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 7 · 256 observed states.
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 300 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 850087 Internal RxNorm lookup 850091 Internal RxNorm lookup 900156 Internal RxNorm lookup 900164 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 0228-1580-03 Lamotrigine 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-1580 LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 24 Current NDC, Legacy NDC, 1 package rows 20250523_87beaf22-593d-4170-bb58-332c615ef90d.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 Marketing end Sample Exclude flag Status 0228-1580-03 00228158003 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1580-03) 2016-04-01 0000-00-00 No No Current