Clopidogrel bisulfate

Product NDC
0615-8625
11-digit product format
006158625
Labeler code
0615
Product ID
0615-8625_4c94d725-7d0f-41ea-b853-b292af783896
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
ANDA204165
Marketing category
ANDA
Marketing start
2015-09-15
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 bisulfate
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
0615-8625-05Clopidogrel bisulfate15 in 1 BLISTER PACKTABLET, FILM COATED151
0615-8625-07Clopidogrel bisulfate7 in 1 BLISTER PACKTABLET, FILM COATED71
0615-8625-30Clopidogrel bisulfate5 in 1 BLISTER PACKTABLET, FILM COATED51
0615-8625-30Clopidogrel bisulfate6 in 1 BOX, UNIT-DOSETABLET, FILM COATED61
0615-8625-39Clopidogrel bisulfate30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN8406b8e3-e203-402f-8858-2748119e23511
309362clopidogrel 75 MG Oral TabletSCD8406b8e3-e203-402f-8858-2748119e23511
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY8406b8e3-e203-402f-8858-2748119e23511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8625-050061586250515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8625-05) 2026-02-17NoNoCurrent
0615-8625-07006158625077 TABLET, FILM COATED in 1 BLISTER PACK (0615-8625-07) 2026-02-17NoNoCurrent
0615-8625-30006158625306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8625-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2026-02-13NoNoCurrent
0615-8625-390061586253930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8625-39) 2026-02-17NoNoCurrent