Clopidogrel

Product NDC
68084-536
11-digit product format
680840536
Labeler code
68084
Product ID
68084-536_2c3a4450-fdb9-1ef8-e063-6294a90ab226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076274
Marketing category
ANDA
Marketing start
2014-04-24
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
68084-536-01Clopidogrel100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10013
68084-536-11Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-536CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]13Current NDC, Legacy NDC, 2 package rows20250122_65ea4dc6-acb2-4609-9a4c-4866ef0ccb11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
309362clopidogrel 75 MG Oral TabletPSN65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
749196clopidogrel 300 MG Oral TabletSCD65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
309362clopidogrel 75 MG Oral TabletSCD65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
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 startMarketing endSampleExclude flagStatus
68084-536-0168084053601100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-536-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-536-11) 100 blister pack2014-04-240000-00-00NoNoCurrent
68084-536-11680840536111 in 1 BLISTER PACKHistorical