FDA.reportPublic FDA data

CLOPIDOGREL

Product NDC
50090-7466
11-digit product format
500907466
Labeler code
50090
Product ID
50090-7466_94be39aa-7d70-4a4b-8e35-454a98cd99f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL BISULFATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203632
Marketing category
ANDA
Marketing start
2024-05-16
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
50090-7466-0CLOPIDOGREL30 in 1 BOTTLETABLET301
50090-7466-1CLOPIDOGREL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7466-0EA - Each50090-7466314a2b89-9e9d-4fe3-83c3-4dcb4db5cbbe12025-01-14
50090-7466-1EA - Each50090-746641af69d5-f2db-415a-9f2f-c2e16cd9c45012025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7466CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241208_2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN2564e8ee-fa2d-49d1-9a1a-6f3eb1e740321
309362clopidogrel 75 MG Oral TabletSCD2564e8ee-fa2d-49d1-9a1a-6f3eb1e740321
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY2564e8ee-fa2d-49d1-9a1a-6f3eb1e740321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7466-05009074660030 TABLET in 1 BOTTLE (50090-7466-0) 30 tablet2024-12-02NoNoCurrent
50090-7466-15009074660190 TABLET in 1 BOTTLE (50090-7466-1) 90 tablet2024-12-02NoNoCurrent