FDA.reportPublic FDA data

Clopidogrel

Product NDC
42543-713
11-digit product format
425430713
Labeler code
42543
Product ID
42543-713_4b480542-0dd3-4694-9d43-d5fdcdd64a0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2014-11-01
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, 749196

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
42543-713-01Clopidogrel100 in 1 BOTTLETABLET10013
42543-713-05Clopidogrel500 in 1 BOTTLETABLET50013
42543-713-10Clopidogrel1000 in 1 BOTTLETABLET100013
42543-713-30Clopidogrel30 in 1 BOTTLETABLET3013
42543-713-90Clopidogrel90 in 1 BOTTLETABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-713CLOPIDOGREL TABLET [VENSUN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 5 package rows20190220_86ee71f2-850e-4c8e-87f3-c7a618d59d95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN86ee71f2-850e-4c8e-87f3-c7a618d59d9513
309362clopidogrel 75 MG Oral TabletPSN86ee71f2-850e-4c8e-87f3-c7a618d59d9513
749196clopidogrel 300 MG Oral TabletSCD86ee71f2-850e-4c8e-87f3-c7a618d59d9513
309362clopidogrel 75 MG Oral TabletSCD86ee71f2-850e-4c8e-87f3-c7a618d59d9513
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY86ee71f2-850e-4c8e-87f3-c7a618d59d9513
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY86ee71f2-850e-4c8e-87f3-c7a618d59d9513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-713-0142543071301100 TABLET in 1 BOTTLE (42543-713-01) 100 tablet2014-11-010000-00-00NoNoCurrent
42543-713-0542543071305500 TABLET in 1 BOTTLE (42543-713-05) 500 tablet2014-11-010000-00-00NoNoCurrent
42543-713-10425430713101000 TABLET in 1 BOTTLE (42543-713-10) 1000 tablet2014-11-010000-00-00NoNoCurrent
42543-713-304254307133030 TABLET in 1 BOTTLE (42543-713-30) 30 tablet2014-11-010000-00-00NoNoCurrent
42543-713-904254307139090 TABLET in 1 BOTTLE (42543-713-90) 90 tablet2014-11-010000-00-00NoNoCurrent