Lamotrigine

Product NDC: 55648-271
11-digit product format: 556480271
Labeler code: 55648
Product ID: 55648-271_ddc5823c-ca8f-4f63-9d7b-d54c82798452
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Wockhardt Limited
Application: ANDA202498
Marketing category: ANDA
Marketing start: 2012-11-29
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-271		I	Inactivated by FDA	2026-08-03
excluded package	package	55648-271	55648-271-01	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-271	55648-271-02	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-271	55648-271-04	I	Inactivated by FDA	2026-08-03

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-271-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-271-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-271-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-271-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-271-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-271-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-271-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-271-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-271-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-271-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-271-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-271-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-271-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-271-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-271-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-271-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-271-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-271-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-271-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-271-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-271-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-271-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-271-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-271-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-271-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-271-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-271-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-271-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-271-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-271-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-271-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-271-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-271-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-271-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-271-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-271-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-271-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-271-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-271-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-271-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-271-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-271-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-271-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-271-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-271-04	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202498-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-005	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202498-001	AB
A202498-002	AB
A202498-003	AB
A202498-004	AB
A202498-005	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 6 · 205 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	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A202498-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202498-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202498-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202498-005	AB	1	`5bbf6a4d5a75…`

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
55648-271-01	2020-01-31	C162847	48780-1	9d75b9d0-93c4-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 Initial U.S. Approval: 1994
55648-271-02	2020-01-31	C162847	48780-1	9d75b9d0-93c4-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 Initial U.S. Approval: 1994
55648-271-04	2020-01-31	C162847	48780-1	9d75b9d0-93c4-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 Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-271-01	Lamotrigine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
55648-271-02	Lamotrigine	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	1
55648-271-04	Lamotrigine	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	1
55648-271-04	Lamotrigine	10 in 1 CARTON	TABLET, EXTENDED RELEASE	10	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-271	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED]	1	Legacy NDC, 4 package rows	20130105_d3a8267b-979f-431d-baba-4ad3c5aa05e4.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
850087	lamoTRIgine 100 MG 24HR Extended Release Oral Tablet	PSN	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	d3a8267b-979f-431d-baba-4ad3c5aa05e4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-271-01	55648027101	30 in 1 BOTTLE	Historical
55648-271-02	55648027102	500 in 1 BOTTLE	Historical
55648-271-04	55648027104	10 in 1 BLISTER PACK	Historical