FDA.reportPublic FDA data

Clopidogrel

Product NDC
70518-1898
11-digit product format
705181898
Labeler code
70518
Product ID
70518-1898_4987afa4-e527-4ae3-e063-6394a90aa694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090540
Marketing category
ANDA
Marketing start
2019-02-22
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
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
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
70518-1898-0Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1898-1Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1898-2Clopidogrel90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1898CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 3 package rows20250302_3e2539c1-a6ad-4d60-944c-c2e7aa70ce45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN3e2539c1-a6ad-4d60-944c-c2e7aa70ce4514
309362clopidogrel 75 MG Oral TabletSCD3e2539c1-a6ad-4d60-944c-c2e7aa70ce4514
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY3e2539c1-a6ad-4d60-944c-c2e7aa70ce4514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1898-07051818980030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1898-0) 2019-02-22NoNoCurrent
70518-1898-17051818980130 in 1 BLISTER PACKHistorical
70518-1898-27051818980290 in 1 BOTTLE, PLASTICHistorical