Clopidogrel bisulfate

Product NDC
82009-182
11-digit product format
820090182
Labeler code
82009
Product ID
82009-182_b225308c-50b5-6c91-fc03-1506c1b2dedc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA091023
Marketing category
ANDA
Marketing start
2025-09-05
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 bisulfate
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
82009-182-05Clopidogrel bisulfate500 in 1 BOTTLETABLET, FILM COATED5002
82009-182-90Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-182-05EA - Each82009-18215f07f98-6455-49c1-a02b-4024dc839db812025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNd072b6ea-2bb4-8965-918e-23f9080efcb02
309362clopidogrel 75 MG Oral TabletSCDd072b6ea-2bb4-8965-918e-23f9080efcb02
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYd072b6ea-2bb4-8965-918e-23f9080efcb02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82009-182-0582009018205500 TABLET, FILM COATED in 1 BOTTLE (82009-182-05) 2025-09-05NoNoCurrent
82009-182-908200901829090 in 1 BOTTLEHistorical