Lamotrigine

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-10-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-05-31 21:45:39

Label at a glance#

ProductLamotrigine

Active ingredientLAMOTRIGINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lamotrigine Tablets (Chewable, Dispersible), 5 mg

NDC 65841-689-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets (Chewable, Dispersible), 5 mg

Lamotrigine Tablets (Chewable, Dispersible), 25 mg

NDC 65841-690-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets (Chewable, Dispersible), 25 mg

Lamotrigine Tablets USP, 25 mg

NDC 65841-682-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets USP, 50 mg

NDC 65841-683-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets USP, 100 mg

NDC 65841-684-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets USP, 150 mg

NDC 65841-685-14 in bottle of 60 tablets

60 tablets

Rx only

Lamotrigine Tablets USP, 200 mg

NDC 65841-686-14 in bottle of 60 tablets

60 tablets

Rx only

Lamotrigine Tablets USP, 250 mg

NDC 65841-687-05 in bottle of 500 tablets

500 tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198427	lamoTRIgine 100 MG Oral Tablet	PSN	12
198428	lamoTRIgine 150 MG Oral Tablet	PSN	12
198429	lamoTRIgine 200 MG Oral Tablet	PSN	12
282401	lamoTRIgine 25 MG Oral Tablet	PSN	12
311264	lamoTRIgine 25 MG Tablet for Oral Suspension	PSN	12
249329	lamoTRIgine 250 MG Oral Tablet	PSN	12
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	12
199322	lamoTRIgine 50 MG Oral Tablet	PSN	12
198427	lamotrigine 100 MG Oral Tablet	SCD	12
198428	lamotrigine 150 MG Oral Tablet	SCD	12
198429	lamotrigine 200 MG Oral Tablet	SCD	12
282401	lamotrigine 25 MG Oral Tablet	SCD	12
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	12
249329	lamotrigine 250 MG Oral Tablet	SCD	12
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	12
199322	lamotrigine 50 MG Oral Tablet	SCD	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LAMOTRIGINE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20220119

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-682-01	Lamotrigine	100 in 1 BOTTLE	TABLET	100	12
65841-682-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	12
65841-682-10	Lamotrigine	1000 in 1 BOTTLE	TABLET	1000	12
65841-682-11	Lamotrigine	25 in 1 BOTTLE	TABLET	25	12
65841-682-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	12
65841-683-01	Lamotrigine	100 in 1 BOTTLE	TABLET	100	12
65841-683-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	12
65841-683-10	Lamotrigine	1000 in 1 BOTTLE	TABLET	1000	12
65841-683-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	12
65841-684-01	Lamotrigine	100 in 1 BOTTLE	TABLET	100	12
65841-684-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	12
65841-684-10	Lamotrigine	1000 in 1 BOTTLE	TABLET	1000	12
65841-684-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	12
65841-685-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	12
65841-685-14	Lamotrigine	60 in 1 BOTTLE	TABLET	60	12
65841-685-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	12
65841-686-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	12
65841-686-14	Lamotrigine	60 in 1 BOTTLE	TABLET	60	12
65841-686-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	12
65841-687-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	12
65841-687-14	Lamotrigine	60 in 1 BOTTLE	TABLET	60	12
65841-687-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	12
65841-689-01	Lamotrigine	100 in 1 BOTTLE	TABLET, CHEWABLE	100	12
65841-689-05	Lamotrigine	500 in 1 BOTTLE	TABLET, CHEWABLE	500	12
65841-689-16	Lamotrigine	90 in 1 BOTTLE	TABLET, CHEWABLE	90	12
65841-690-01	Lamotrigine	100 in 1 BOTTLE	TABLET, CHEWABLE	100	12
65841-690-05	Lamotrigine	500 in 1 BOTTLE	TABLET, CHEWABLE	500	12
65841-690-16	Lamotrigine	90 in 1 BOTTLE	TABLET, CHEWABLE	90	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	2
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
BLACK CURRANT	INACTIVE INGREDIENT	9755T40D11	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	2
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Lamotrigine
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
ASPARTAME
CROSCARMELLOSE SODIUM
MANNITOL
TRIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
BLACK CURRANT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-682	65841-682-16, 65841-682-01, 65841-682-05, 65841-682-10, 65841-682-11
65841-683	65841-683-16, 65841-683-01, 65841-683-05, 65841-683-10
65841-684	65841-684-16, 65841-684-01, 65841-684-05, 65841-684-10
65841-685	65841-685-14, 65841-685-16, 65841-685-05
65841-686	65841-686-14, 65841-686-16, 65841-686-05
65841-687	65841-687-14, 65841-687-16, 65841-687-05
65841-689	65841-689-16, 65841-689-01, 65841-689-05
65841-690	65841-690-16, 65841-690-01, 65841-690-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LAMOTRIGINE	U3H27498KS	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LAMOTRIGINE	U3H27498KS	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LAMOTRIGINE	U3H27498KS	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LAMOTRIGINE	U3H27498KS	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LAMOTRIGINE	U3H27498KS	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LAMOTRIGINE	U3H27498KS	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LAMOTRIGINE	U3H27498KS	ACTIB
ASPARTAME	Z0H242BBR1	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 360 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL	254 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET / ORAL	330 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
BLACK CURRANT	BLACK CURRANT	9755T40D11	SOLUTION / ORAL	213 mg	Exact identifier — unii+route 36 equally ranked IID candidates
BLACK CURRANT	BLACK CURRANT	9755T40D11	SOLUTION / ORAL	213 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL	1725 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL	216 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET / ORAL	330 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL	1725 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL	48 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
BLACK CURRANT	BLACK CURRANT	9755T40D11	SOLUTION / ORAL	213 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL	254 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL	3726 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL	48 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL	3726 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL	127 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET / ORAL	330 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
BLACK CURRANT	BLACK CURRANT	9755T40D11	SOLUTION / ORAL	213 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET / ORAL	330 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
BLACK CURRANT	BLACK CURRANT	9755T40D11	SOLUTION / ORAL	213 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET / ORAL	330 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL	127 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL	48 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL	87 mg	Exact identifier — unii+route+dosage form 36 equally ranked IID candidates
BLACK CURRANT	BLACK CURRANT	9755T40D11	SOLUTION / ORAL	213 mg	Exact identifier — unii+route 36 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 2 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077633-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A077633-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27
A077633-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A077633-004	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A077633-005	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27
A077633-006	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET / ORAL		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
A077633-001	AB
A077633-003	AB
A077633-004	AB
A077633-005	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 7 · 258 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
2026-09-14 22:38:34	2026-08	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077633-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077633-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077633-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077633-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-005	AB	1	`5bbf6a4d5a75…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078009-002	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-01-22
A078009-003	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078009-002	AB
A078009-003	AB

Observed Orange Book product history#

Product history page 1 of 3 · 86 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
2026-09-14 22:38:34	2026-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078009-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078009-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-01-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078009-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078009-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078009-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078009-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078009-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078009-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078009-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078009-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078009-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078009-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078009-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078009-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078009-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078009-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078009-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078009-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078009-003	AB	1	`74a2ff9319b5…`

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
Lamotrigine	LAMOTRIGINE	Zydus Lifesciences Limited	0f2f7421-56d4-45d0-9d2d-dc1edaede039	2025-10-04		Exact identifier ndc (package): 65841-686-14 ndc (package): 65841-683-16 ndc (package): 65841-690-16 ndc (package): 65841-682-16 ndc (package): 65841-683-01 ndc (package): 65841-682-10 ndc (package): 65841-683-10 ndc (package): 65841-683-05 ndc (package): 65841-687-05 ndc (package): 65841-684-16 ndc (package): 65841-690-01 ndc (package): 65841-684-05 ndc (package): 65841-685-16 ndc (package): 65841-682-01 ndc (package): 65841-686-16 ndc (package): 65841-686-05 ndc (package): 65841-689-16 ndc (package): 65841-684-10 ndc (package): 65841-684-01 ndc (package): 65841-689-05 ndc (package): 65841-685-05 ndc (package): 65841-690-05 ndc (package): 65841-687-14 ndc (package): 65841-682-11 ndc (package): 65841-687-16 ndc (package): 65841-689-01 ndc (package): 65841-685-14 ndc (package): 65841-682-05 ndc (product): 65841-683 ndc (product): 65841-690 ndc (product): 65841-686 ndc (product): 65841-685 ndc (product): 65841-687 ndc (product): 65841-689 ndc (product): 65841-684 ndc (product): 65841-682 ndc11 (package): 65841068410 ndc11 (package): 65841068310 ndc11 (package): 65841068211 ndc11 (package): 65841068216 ndc11 (package): 65841068505 ndc11 (package): 65841068405 ndc11 (package): 65841068416 ndc11 (package): 65841068205 ndc11 (package): 65841068514 ndc11 (package): 65841068901 ndc11 (package): 65841069001 ndc11 (package): 65841068516 ndc11 (package): 65841068210 ndc11 (package): 65841068301 ndc11 (package): 65841068614 ndc11 (package): 65841068916 ndc11 (package): 65841068201 ndc11 (package): 65841069016 ndc11 (package): 65841068705 ndc11 (package): 65841068616 ndc11 (package): 65841068716 ndc11 (package): 65841068714 ndc11 (package): 65841068401 ndc11 (package): 65841069005 ndc11 (package): 65841068305 ndc11 (package): 65841068316 ndc11 (package): 65841068605 ndc11 (package): 65841068905 spl id: c4eb074b-9cd4-4bcd-868c-473d9364061c spl set id: 0f2f7421-56d4-45d0-9d2d-dc1edaede039

Reported adverse events (FAERS/openFDA)#

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