Clopidogrel

Product NDC
0615-8014
11-digit product format
006158014
Labeler code
0615
Product ID
0615-8014_b5b91d67-b29c-4568-a76b-079a429352d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA076274
Marketing category
ANDA
Marketing start
2012-05-17
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel

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
0615-8014-05Clopidogrel15 in 1 BLISTER PACKTABLET, FILM COATED1526
0615-8014-07Clopidogrel7 in 1 BLISTER PACKTABLET, FILM COATED726
0615-8014-30Clopidogrel5 in 1 BLISTER PACKTABLET, FILM COATED526
0615-8014-30Clopidogrel6 in 1 BOX, UNIT-DOSETABLET, FILM COATED626
0615-8014-39Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED3026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8014CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]25Current NDC, Legacy NDC, 5 package rows20240919_d14849e1-58f8-44de-9a9d-a1bb23d1f294.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNd14849e1-58f8-44de-9a9d-a1bb23d1f29426
309362clopidogrel 75 MG Oral TabletSCDd14849e1-58f8-44de-9a9d-a1bb23d1f29426
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYd14849e1-58f8-44de-9a9d-a1bb23d1f29426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8014-050061580140515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8014-05) 2016-05-042026-07-31NoNoCurrent
0615-8014-07006158014077 TABLET, FILM COATED in 1 BLISTER PACK (0615-8014-07) 2024-08-032026-07-31NoNoHistorical
0615-8014-30006158014306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8014-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2016-05-192026-07-31NoNoCurrent
0615-8014-390061580143930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8014-39) 2016-05-042026-07-31NoNoCurrent