Clopidogrel

Product NDC: 68071-2813
11-digit product format: 680712813
Labeler code: 68071
Product ID: 68071-2813_e64d03ac-4409-3d5a-e053-2995a90a7c5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202925
Marketing category: ANDA
Marketing start: 2013-11-21
Marketing end: 0000-00-00
Substance: CLOPIDOGREL BISULFATE
Active strength: 75 mg/1
Pharmacologic classes: Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
39fa80eb-1490-ce82-3d3a-820ae7c37b85	Product name	5	20250618

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2813-9	2025-01-30	C162847	48780-1	2cef2736-6848-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2813-9	Clopidogrel	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2813	CLOPIDOGREL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220817_e64dfbbc-810a-662a-e053-2995a90abb42.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08I79HTP27	CLOPIDOGREL BISULFATE	120202-66-6	CLOPIDOGREL BISULFATE
A74586SNO7	CLOPIDOGREL	113665-84-2	Clopidogrel

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309362	clopidogrel 75 MG Oral Tablet	PSN	e64dfbbc-810a-662a-e053-2995a90abb42	1
309362	clopidogrel 75 MG Oral Tablet	SCD	e64dfbbc-810a-662a-e053-2995a90abb42	1
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	e64dfbbc-810a-662a-e053-2995a90abb42	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2813-9	68071281309	90 TABLET, FILM COATED in 1 BOTTLE (68071-2813-9)	2022-08-15	0000-00-00	No	No	Current