Clopidogrel bisulfate

Product NDC
72162-2212
11-digit product format
721622212
Labeler code
72162
Product ID
72162-2212_0ae0a458-0119-486c-a658-698a6b7a3695
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
72162-2212-0Clopidogrel bisulfate1000 in 1 BOTTLETABLET, FILM COATED1000100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2212-0EA - Each72162-221245642255-2fa4-4c87-962d-699f4d9af3c612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2212CLOPIDOGREL BISULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240106_539265a6-e356-42cd-bde9-ac704f108c74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN539265a6-e356-42cd-bde9-ac704f108c74100
309362clopidogrel 75 MG Oral TabletSCD539265a6-e356-42cd-bde9-ac704f108c74100
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY539265a6-e356-42cd-bde9-ac704f108c74100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2212-0721622212001000 TABLET, FILM COATED in 1 BOTTLE (72162-2212-0) 2024-01-05NoNoCurrent