Home NDC 55111-718-30 Lamotrigine
Product NDC 55111-718
Requested package NDC 55111-718-30
11-digit product format 551110718
Labeler code 55111
Product ID 55111-718_236437dc-fce9-b140-992c-b7822562eee5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Dr.Reddy's Laboratories Limited
Application ANDA202383
Marketing category ANDA
Marketing start 2013-06-20
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 45 .
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 A202383-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 A202383-002 LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 A202383-003 LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 A202383-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 A202383-005 LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 A202383-006 LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06
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 · 266 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 2026-11-14 07:37:17 2026-10 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202383-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202383-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202383-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202383-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202383-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202383-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202383-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202383-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202383-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202383-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202383-005 LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202383-006 LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE / ORAL AB 2018-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202383-001 LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202383-002 LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202383-003 LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202383-004 LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2013-06-19 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 266 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 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 · 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 55111-718-05 Lamotrigine 500 in 1 BOTTLE TABLET, EXTENDED RELEASE 500 29 55111-718-30 Lamotrigine 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMOTRIGINE ACTIVE INGREDIENT U3H27498KS LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 LAMOTRIGINE ACTIVE MOIETY U3H27498KS LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 SHELLAC INACTIVE INGREDIENT 46N107B71O LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 TALC INACTIVE INGREDIENT 7SEV7J4R1U LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-718 LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] 27 Current NDC, Legacy NDC, 2 package rows 20210528_a69542ea-5b6f-15c1-9e7a-90ac839971d3.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 · 3 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 55111-718-30 55111071830 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-718-30) 2013-06-20 0000-00-00 No No Current