Lamotrigine

Product NDC: 13668-342
Requested package NDC: 13668-342-30
11-digit product format: 136680342
Labeler code: 13668
Product ID: 13668-342_e789ab79-4ccb-514e-e053-2a95a90a0651
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA203370
Marketing category: ANDA
Marketing start: 2013-12-23
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13668-342	13668-342-30	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A203370-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203370-001	AB
A203370-002	AB
A203370-003	AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203370-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203370-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203370-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203370-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203370-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203370-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203370-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203370-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203370-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203370-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203370-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203370-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203370-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
14a9502b-3d70-0496-a7e1-b16edaa005b8	Product name	5	20250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0	Product name	7	20250401
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13668-342-01	Lamotrigine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		19
13668-342-30	Lamotrigine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-342-30	EA - Each	13668-342	3a63fb75-5aee-4c5f-8ac9-85f94d1a56df	1	2018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-342	LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	16	Legacy NDC, 2 package rows	20241017_52df02a7-83da-4b20-9951-69790237dc24.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	de7f61ca-e3c0-4a09-b664-0df2de6a0c30	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370
Lamotrigine	LAMOTRIGINE	Torrent Pharmaceuticals Limited	52df02a7-83da-4b20-9951-69790237dc24	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370 ndc (package): 13668-342-30 ndc (product): 13668-342 ndc11 (package): 13668034230
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
850087	lamoTRIgine 100 MG 24HR Extended Release Oral Tablet	PSN	52df02a7-83da-4b20-9951-69790237dc24	19
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	52df02a7-83da-4b20-9951-69790237dc24	19
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	52df02a7-83da-4b20-9951-69790237dc24	19
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	52df02a7-83da-4b20-9951-69790237dc24	19
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	52df02a7-83da-4b20-9951-69790237dc24	19
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	52df02a7-83da-4b20-9951-69790237dc24	19
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	52df02a7-83da-4b20-9951-69790237dc24	19
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	52df02a7-83da-4b20-9951-69790237dc24	19
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	52df02a7-83da-4b20-9951-69790237dc24	19
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	52df02a7-83da-4b20-9951-69790237dc24	19
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	52df02a7-83da-4b20-9951-69790237dc24	19
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	52df02a7-83da-4b20-9951-69790237dc24	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-342-30	13668034230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-342-30)	2013-12-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	19