FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
70518-4110
11-digit product format
705184110
Labeler code
70518
Product ID
70518-4110_3fa4edcb-fbd4-5153-e063-6294a90abab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2024-06-24
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
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
70518-4110-0Clopidogrel bisulfate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
70518-4110-1Clopidogrel bisulfate30 in 1 BLISTER PACKTABLET, FILM COATED306
70518-4110-2Clopidogrel bisulfate30 in 1 BLISTER PACKTABLET, FILM COATED306
70518-4110-3Clopidogrel bisulfate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
70518-4110-4Clopidogrel bisulfate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4110CLOPIDOGREL BISULFATE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, 5 package rows20250327_2969deac-274b-4042-9c90-9522e62a979d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN2969deac-274b-4042-9c90-9522e62a979d6
309362clopidogrel 75 MG Oral TabletSCD2969deac-274b-4042-9c90-9522e62a979d6
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY2969deac-274b-4042-9c90-9522e62a979d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4110-07051841100090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4110-0) 2024-06-24NoNoHistorical
70518-4110-17051841100130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4110-1) 2024-07-11NoNoHistorical
70518-4110-27051841100230 TABLET, FILM COATED in 1 BLISTER PACK (70518-4110-2) 2024-12-17NoNoHistorical
70518-4110-37051841100390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4110-3) 2025-02-18NoNoHistorical
70518-4110-47051841100430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4110-4) 2025-03-24NoNoHistorical