Lamotrigine

Product NDC: 68788-7465
Requested package NDC: 68788-7465-6
11-digit product format: 687887465
Labeler code: 68788
Product ID: 68788-7465_12fa415c-5157-4229-9ff1-b7db7a8b2c66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA079132
Marketing category: ANDA
Marketing start: 2019-12-27
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: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	68788-7465	68788-7465-6	D	Discontinued by firm		2026-07-31

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
A079132-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A079132-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A079132-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A079132-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A079132-001	AB
A079132-002	AB
A079132-003	AB
A079132-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A079132-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079132-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079132-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079132-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	AvKARE	fcdb94a8-33be-6375-98ef-6933999d157f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079132 application number: ANDA079132
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	d33c4293-347c-49a1-9d98-f291c3dab6da	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079132 application number: ANDA079132
Lamotrigine	LAMOTRIGINE	Jubilant Cadista Pharmacuticals Inc.	0b0f0209-edbd-46f3-9bed-762cbea0d737	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079132 application number: ANDA079132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7465-3	EA - Each	68788-7465	2a75a5c1-4a7e-47db-93a4-c8a4b55647ec	1	2020-08-06
68788-7465-6	EA - Each	68788-7465	eb1abd9c-d2df-4572-ab36-eb7a1c053a17	1	2020-08-06
68788-7465-9	EA - Each	68788-7465	3c27d297-2c16-470e-b642-c4314edddad0	1	2020-08-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7465-6	68788746506	60 TABLET in 1 BOTTLE (68788-7465-6)	60 tablet	2019-12-27	0000-00-00	No	No	Current