NDC 64679-271-03 - Lamotrigine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 64679-271
Requested NDC: 64679-271-03
Package NDCs from labels: 64679-271-01, 64679-271-02, 64679-271-03, 64679-271-04
Manufacturer: Wockhardt USA LLC. | Atlantide Pharmaceuticals AG | Wockhardt Limited
Effective date: 2020-12-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lamotrigine - Wockhardt USA LLC. \| Atlantide Pharmaceuticals AG \| Wockhardt Limited	Wockhardt USA LLC. \| Atlantide Pharmaceuticals AG \| Wockhardt Limited	2020-12-27	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-271-01	2025-12-23	These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-02	2025-12-23	These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-04	2025-12-23	These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-01	2023-01-30	These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-02	2023-01-30	These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-04	2023-01-30	These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64679-271	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	5	Legacy NDC	20201228_0e9b23d9-0813-4fb5-848d-776453f361f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-271-01	EA - Each	64679-271	898db821-9b41-4321-b09a-c25cbab6eda0	1	2013-02-13
64679-271-02	EA - Each	64679-271	2487e671-fa12-49d2-8a3e-97d067ea1d0b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2

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 27 of 113 · 2,260 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus	TITANIUM DIOXIDE	HEY HONEY INC.	21187805-fae9-476c-81b0-27ffeb0b9911	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
Bellas Friends Roll-on Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	PANERGYTEK USA INC	478d46ce-14e8-2231-e063-6394a90a3e27	2026-01-04	Warnings	Exact identifier unii: 15FIX9V2JP
Lamotrigine	LAMOTRIGINE	Quallent Pharmaceuticals Health LLC	7977c87f-b459-486a-9edc-0a2071c46f4c	2026-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	03fd8413-df56-50ab-e063-6394a90a6950	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	db5f7ee5-9bd9-1819-e053-2a95a90a91df	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
LAMOTRIGINE	LAMOTRIGINE	Northwind Health Company, LLC	f7587283-781b-e111-e053-6394a90ad4cc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47428cd4-fbad-ba7a-e063-6394a90a1c5c	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47433a62-91e0-b031-e063-6294a90a0d49	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4743b6a9-4d79-1b2b-e063-6394a90a9710	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4744e501-f12a-6d25-e063-6394a90a2574	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47456bf5-9f6c-e6a5-e063-6294a90a7054	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ab56-abaa-42de-e063-6394a90a6310	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ebec-acb0-77c4-e063-6394a90aee07	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47461ad3-a11e-2a11-e063-6294a90a0f8f	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dermagesic	PRAMOXINE HCL, ZINC OXIDE, CALAMINE	Llorens Pharmaceutical International Division	bbff6b53-29da-45c1-8ccd-3e9df7f250e0	2025-12-31	Warnings	Exact identifier unii: 1K09F3G675
Sei Bella CC Brightening Creme Light	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6894b9d9-a5b5-4c98-e053-2991aa0a9ca2	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Fair	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6892952a-d032-30bf-e053-2a91aa0a3bba	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Medium Tan	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4e8b4-36cb-6306-e053-2a91aa0a6d25	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Medium	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4ed34-f492-67a6-e053-2a91aa0a0428	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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