Clopidogrel

Product NDC: 68645-430
11-digit product format: 686450430
Labeler code: 68645
Product ID: 68645-430_1191b0c2-049d-4401-8a63-e92d8ef3908c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging
Application: ANDA076999
Marketing category: ANDA
Marketing start: 2012-05-17
Marketing end: 0000-00-00
Substance: CLOPIDOGREL BISULFATE
Active strength: 75 mg/1
Pharmacologic classes: Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
68645-430-54	2020-01-31	C162847	48780-1	9d75b9d0-5b5a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use clopidogrel tablets USP safely and effectively. See full prescribing information for clopidogrel tablets USP. CLOPIDOGREL tablets USP for oral use Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68645-430-54	Clopidogrel	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-430	CLOPIDOGREL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4	Legacy NDC, 1 package rows	20121005_2e8d1503-a431-40ca-95bc-285557795bf7.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	2e8d1503-a431-40ca-95bc-285557795bf7	4
309362	clopidogrel 75 MG Oral Tablet	SCD	2e8d1503-a431-40ca-95bc-285557795bf7	4
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	2e8d1503-a431-40ca-95bc-285557795bf7	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68645-430-54	68645043054	30 in 1 BOTTLE	Historical