Clopidogrel

Product NDC
68645-590
11-digit product format
686450590
Labeler code
68645
Product ID
68645-590_4c21fe89-421c-249a-e063-6294a90aad2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA090540
Marketing category
ANDA
Marketing start
2012-05-17
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
68645-590-90Clopidogrel90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-590-90EA - Each68645-590a1ee71a8-9c2d-4dd5-aff1-e786f5b5006c12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-590CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC]8Current NDC, Legacy NDC, 1 package rows20250313_53de10a5-dbd0-413d-90e5-00a1920ec391.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN53de10a5-dbd0-413d-90e5-00a1920ec3919
309362clopidogrel 75 MG Oral TabletSCD53de10a5-dbd0-413d-90e5-00a1920ec3919
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY53de10a5-dbd0-413d-90e5-00a1920ec3919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68645-590-906864505909090 TABLET, FILM COATED in 1 BOTTLE (68645-590-90) 2012-05-170000-00-00NoNoCurrent