LAMICTAL

Product NDC: 0173-0754
11-digit product format: 001730754
Labeler code: 0173
Product ID: 0173-0754_0c7b21d8-3c32-4c65-95cd-cada0421d8e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA022115
Marketing category: NDA
Marketing start: 2009-07-06
Substance: LAMOTRIGINE
Active strength: 25 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: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2025-02-02 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	0173-0754-00	`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	0173-0754-00	`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	0173-0754-00	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
N022115-001	LAMICTAL XR	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29
N022115-002	LAMICTAL XR	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29
N022115-003	LAMICTAL XR	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29
N022115-004	LAMICTAL XR	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29
N022115-005	LAMICTAL XR	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14
N022115-006	LAMICTAL XR	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N022115-001	AB
N022115-002	AB
N022115-003	AB
N022115-004	AB
N022115-005	AB
N022115-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022115-001	8637512	2029-01-07	Drug product	2014-02-12
N022115-002	8637512	2029-01-07	Drug product	2014-02-12
N022115-003	8637512	2029-01-07	Drug product	2014-02-12
N022115-004	8637512	2029-01-07	Drug product	2014-02-12
N022115-005	8637512	2029-01-07	Drug product	2014-02-12
N022115-006	8637512	2029-01-07	Drug product	2014-02-12

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 · 246 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
2026-02-19 14:30 UTC	2026-02	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N022115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022115-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022115-001	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-002	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-003	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-004	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-005	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-006	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-001	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-002	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-003	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-004	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-005	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-006	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022115-001	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-002	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-003	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-004	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-005	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-006	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-005	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-006	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-005	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-006	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-005	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-006	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: LAMICTAL
Brand name suffix: XR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	25 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 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
850087	Internal RxNorm lookup
850091	Internal RxNorm lookup
900145	Internal RxNorm lookup
900156	Internal RxNorm lookup
900157	Internal RxNorm lookup
900164	Internal RxNorm lookup
900165	Internal RxNorm lookup
900169	Internal RxNorm lookup
900865	Internal RxNorm lookup
900866	Internal RxNorm lookup
900890	Internal RxNorm lookup
900891	Internal RxNorm lookup
900983	Internal RxNorm lookup
900984	Internal RxNorm lookup
1098608	Internal RxNorm lookup
1098610	Internal RxNorm lookup
1146690	Internal RxNorm lookup
1146692	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	Available on FDA.report

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
0173-0754-00	2025-02-01	C162847	48780-1	2cef2736-ac26-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR (lamotrigine) extended-release tablets, for oral use Initial U.S. Approval: 1994
0173-0754-00	2025-02-01	C162847	48780-1	2cef2736-ac26-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR (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
0173-0754-00	LAMICTALXR	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0754-00	EA - Each	0173-0754	46536586-5b0e-4a5b-b477-327049a3aa4e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
COCHINEAL	INACTIVE INGREDIENT	TZ8Z31B35M	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0754	LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	42	Current NDC, Legacy NDC, 1 package rows	20250507_3e2c9a35-6a39-41d7-ad84-3c0bb8894b09.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMICTAL XR	LAMOTRIGINE	GlaxoSmithKline LLC	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022115 application number: NDA022115 ndc (product): 0173-0754

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
900866	{14 (24 HR lamotrigine 100 MG Extended Release Oral Tablet [Lamictal]) / 7 (24 HR lamotrigine 200 MG Extended Release Oral Tablet [Lamictal]) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]) } Pack [Lamictal XR Green Patient Titration Kit (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate)]	BPCK	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900984	{21 (24 HR lamotrigine 25 MG Extended Release Oral Tablet [Lamictal]) / 7 (24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]) } Pack [Lamictal XR Blue Patient Titration Kit (for Patients Taking Valproate)]	BPCK	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900891	{7 (24 HR lamotrigine 100 MG Extended Release Oral Tablet [Lamictal]) / 14 (24 HR lamotrigine 25 MG Extended Release Oral Tablet [Lamictal]) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]) } Pack [Lamictal XR Orange Patient Titration Kit (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)]	BPCK	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900865	{14 (24 HR lamotrigine 100 MG Extended Release Oral Tablet) / 7 (24 HR lamotrigine 200 MG Extended Release Oral Tablet) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet) } Pack	GPCK	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900983	{21 (24 HR lamotrigine 25 MG Extended Release Oral Tablet) / 7 (24 HR lamotrigine 50 MG Extended Release Oral Tablet) } Pack	GPCK	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900890	{7 (24 HR lamotrigine 100 MG Extended Release Oral Tablet) / 14 (24 HR lamotrigine 25 MG Extended Release Oral Tablet) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet) } Pack	GPCK	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900145	LaMICtal XR 100 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900157	LaMICtal XR 200 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900165	LaMICtal XR 25 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146692	LaMICtal XR 250 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098610	LaMICtal XR 300 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900169	LaMICtal XR 50 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900984	LaMICtal XR Patient Titration Kit Blue 25 MG (21), 50 MG (7) 28 Count	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900866	LaMICtal XR Patient Titration Kit Green 50 MG (14), 100 MG (14), 200 MG (7) 35 Count	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900891	LaMICtal XR Patient Titration Kit Orange 25 MG (14), 50 MG (14), 100 MG (7) 35 Count	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
850087	lamoTRIgine 100 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900983	lamoTRIgine 25 MG (21), 50 MG (7) 24HR Extended Release Oral Tablet 28 Count Pack	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900865	lamoTRIgine 50 MG (14), 100 MG (14), 200 MG (7) 24 HR Extended Release Oral Tablet 35 Count Pack	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900145	24 HR lamotrigine 100 MG Extended Release Oral Tablet [Lamictal]	SBD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900157	24 HR lamotrigine 200 MG Extended Release Oral Tablet [Lamictal]	SBD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900165	24 HR lamotrigine 25 MG Extended Release Oral Tablet [Lamictal]	SBD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146692	24 HR lamotrigine 250 MG Extended Release Oral Tablet [Lamictal]	SBD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098610	24 HR lamotrigine 300 MG Extended Release Oral Tablet [Lamictal]	SBD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900169	24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]	SBD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900865	14 lamotrigine 100 MG 24 HR Extended Release Oral Tablet / 7 lamotrigine 200 MG 24 HR Extended Release Oral Tablet / 14 lamotrigine 50 MG 24 HR Extended Release Oral Tablet Pack	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900983	21 lamotrigine 25 MG 24 HR Extended Release Oral Tablet / 7 lamotrigine 50 MG 24 HR Extended Release Oral Tablet Pack	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900890	7 lamotrigine 100 MG 24 HR Extended Release Oral Tablet / 14 lamotrigine 25 MG 24 HR Extended Release Oral Tablet / 14 lamotrigine 50 MG 24 HR Extended Release Oral Tablet Pack	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900145	Lamictal 100 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900157	Lamictal 200 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900165	Lamictal 25 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146692	Lamictal 250 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098610	Lamictal 300 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900169	Lamictal 50 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900145	Lamictal XR 100 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900157	Lamictal XR 200 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900165	Lamictal XR 25 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146692	Lamictal XR 250 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098610	Lamictal XR 300 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900169	Lamictal XR 50 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900984	Lamictal XR Blue Patient Titration Kit	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900984	Lamictal XR Blue Patient Titration Kit (for Patients Taking Valproate)	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900866	Lamictal XR Green Patient Titration Kit	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900866	Lamictal XR Green Patient Titration Kit (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate)	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900891	Lamictal XR Orange Patient Titration Kit	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900891	Lamictal XR Orange Patient Titration Kit (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0754-00	00173075400	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0754-00)	2009-07-06	0000-00-00	No	No	Current