Lamotrigine Extended Release

Product NDC: 63629-7020
Requested package NDC: 63629-7020-1
11-digit product format: 636297020
Labeler code: 63629
Product ID: 63629-7020_b6acfef1-7d89-495a-a642-a47cc7d31e47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine extended release
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201791
Marketing category: ANDA
Marketing start: 2013-01-18
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
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	63629-7020	63629-7020-1	I	Inactivated by FDA		2026-10-30

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 · 16 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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	Approval date
A201791-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18

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 · 264 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
2026-10-15 13:18:30	2026-09	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 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	A201791-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201791-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-004	AB	1	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7020-1	2024-01-30	C162847	48780-1	9d75b9d0-8311-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended release tablets, for oral use. Initial U.S. Approval: 1994
63629-7020-1	2020-10-16	C162847	48780-1	9d75b9d0-8311-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended release tablets, for oral use. Initial U.S. Approval: 1994
63629-7020-1	2020-01-31	C162847	48780-1	9d75b9d0-8311-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended release tablets, for oral use. Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-7020-1	Lamotrigine Extended Release	30 in 1 BOTTLE	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7020	LAMOTRIGINE EXTENDED RELEASE TABLET [BRYANT RANCH PREPACK]	4	Legacy NDC, 1 package rows	20220115_b6acfef1-7d89-495a-a642-a47cc7d31e47.zip

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
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	b6acfef1-7d89-495a-a642-a47cc7d31e47	4
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	b6acfef1-7d89-495a-a642-a47cc7d31e47	4
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	b6acfef1-7d89-495a-a642-a47cc7d31e47	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7020-1	63629702001	30 TABLET in 1 BOTTLE (63629-7020-1)	30 tablet	2016-06-06	0000-00-00	No	No	Current