FDA.reportPublic FDA data

Clopidogrel

Product NDC
50090-6567
11-digit product format
500906567
Labeler code
50090
Product ID
50090-6567_e2142eb8-a5a3-45a3-b6f8-72894ef0c973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202928
Marketing category
ANDA
Marketing start
2022-08-09
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6567-0Clopidogrel30 in 1 BOTTLETABLET303
50090-6567-1Clopidogrel90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6567-0EA - Each50090-6567a7aee472-df9b-41d8-991c-95881360f11212023-09-05
50090-6567-1EA - Each50090-656790fe6415-98e2-4971-84a3-d7730f03d5de12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6567CLOPIDOGREL TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20241003_3c8c68ca-aa48-43f0-977d-2608e1666be4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN3c8c68ca-aa48-43f0-977d-2608e1666be43
309362clopidogrel 75 MG Oral TabletSCD3c8c68ca-aa48-43f0-977d-2608e1666be43
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY3c8c68ca-aa48-43f0-977d-2608e1666be43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6567-05009065670030 TABLET in 1 BOTTLE (50090-6567-0) 30 tablet2023-07-28NoNoCurrent
50090-6567-15009065670190 TABLET in 1 BOTTLE (50090-6567-1) 90 tablet2023-07-28NoNoCurrent