Clopidogrel

Product NDC
55154-2149
11-digit product format
551542149
Labeler code
55154
Product ID
55154-2149_f2c8b1d7-dfbb-488c-b554-3b2d685fd6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076274
Marketing category
ANDA
Marketing start
2025-10-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2149-0Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED13
55154-2149-0Clopidogrel10 in 1 BAGTABLET, FILM COATED103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNc03a895c-2d74-4d7f-891f-b752ce409b683
309362clopidogrel 75 MG Oral TabletSCDc03a895c-2d74-4d7f-891f-b752ce409b683
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYc03a895c-2d74-4d7f-891f-b752ce409b683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2149-05515421490010 BLISTER PACK in 1 BAG (55154-2149-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-10NoNoHistorical