FDA.reportPublic FDA data

Clopidogrel

Product NDC
71610-527
11-digit product format
716100527
Labeler code
71610
Product ID
71610-527_5364ce21-e700-4cce-bd59-aadec2a56428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076274
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel
Listing expiration
2026-12-31

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
71610-527-60Clopidogrel90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-527-60EA - Each71610-5279dc88c20-5fc7-435e-bbd3-435b69ee601912021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-527CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20210320_d49362ae-f78a-47d8-ac14-8262d621fcaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNd49362ae-f78a-47d8-ac14-8262d621fcaa1
309362clopidogrel 75 MG Oral TabletSCDd49362ae-f78a-47d8-ac14-8262d621fcaa1
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYd49362ae-f78a-47d8-ac14-8262d621fcaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-527-607161005276090 TABLET, FILM COATED in 1 BOTTLE (71610-527-60) 2021-02-120000-00-00NoNoCurrent