Clopidogrel

Product NDC
72789-469
11-digit product format
727890469
Labeler code
72789
Product ID
72789-469_2abaa65e-cc80-156c-e063-6294a90a44be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090540
Marketing category
ANDA
Marketing start
2012-05-17
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-469-90Clopidogrel90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-469-90EA - Each72789-4691d6f702f-3925-4607-9475-eb9a113191da12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-469CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]19Current NDC, 1 package rows20250104_20247bf8-30ec-4807-95c1-8ec7587368ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN20247bf8-30ec-4807-95c1-8ec7587368ae19
309362clopidogrel 75 MG Oral TabletSCD20247bf8-30ec-4807-95c1-8ec7587368ae19
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY20247bf8-30ec-4807-95c1-8ec7587368ae19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-469-907278904699090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-469-90) 2025-01-02NoNoCurrent