Clopidogrel bisulfate

Product NDC: 68151-3118
11-digit product format: 681513118
Labeler code: 68151
Product ID: 68151-3118_952416a8-b9eb-4952-bc93-5c7f70c59424
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA076273
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
68151-3118-9	2020-01-31	C162847	48780-1	9d75b9d1-2760-f424-e053-dadaa90a57ce	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
68151-3118-9	Clopidogrel bisulfate	1 in 1 PACKAGE	TABLET, FILM COATED	1		3

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clopidogrel bisulfate	ACTIVE INGREDIENT	08I79HTP27	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
Clopidogrel	ACTIVE MOIETY	A74586SNO7	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-3118	CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3	Legacy NDC, 1 package rows	20160805_9c0263c5-97bd-4fcc-8b0c-c825dbefa4c1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08I79HTP27	CLOPIDOGREL BISULFATE	120202-66-6	CLOPIDOGREL BISULFATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309362	clopidogrel 75 MG Oral Tablet	PSN	9c0263c5-97bd-4fcc-8b0c-c825dbefa4c1	3
309362	clopidogrel 75 MG Oral Tablet	SCD	9c0263c5-97bd-4fcc-8b0c-c825dbefa4c1	3
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	9c0263c5-97bd-4fcc-8b0c-c825dbefa4c1	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-3118-9	68151311809	1 in 1 PACKAGE	Historical