CLOPIDOGREL

Product NDC
31722-758
11-digit product format
317220758
Labeler code
31722
Product ID
31722-758_04d99965-cea0-8e7d-e063-6394a90ab281
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205345
Marketing category
ANDA
Marketing start
2023-08-04
Substance
CLOPIDOGREL
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
CLOPIDOGREL75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA74586SNO7
Rxcui309362, 749196

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
31722-758-05CLOPIDOGREL500 in 1 BOTTLETABLET5001
31722-758-30CLOPIDOGREL30 in 1 BOTTLETABLET301
31722-758-90CLOPIDOGREL90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-758CLOPIDOGREL TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20230910_b573aefa-e337-478f-97e4-eb8472a7e497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNb573aefa-e337-478f-97e4-eb8472a7e4971
309362clopidogrel 75 MG Oral TabletPSNb573aefa-e337-478f-97e4-eb8472a7e4971
749196clopidogrel 300 MG Oral TabletSCDb573aefa-e337-478f-97e4-eb8472a7e4971
309362clopidogrel 75 MG Oral TabletSCDb573aefa-e337-478f-97e4-eb8472a7e4971
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYb573aefa-e337-478f-97e4-eb8472a7e4971
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYb573aefa-e337-478f-97e4-eb8472a7e4971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-758-0531722075805500 TABLET in 1 BOTTLE (31722-758-05) 500 tablet2023-08-04NoNoHistorical
31722-758-303172207583030 TABLET in 1 BOTTLE (31722-758-30) 30 tablet2023-08-04NoNoHistorical
31722-758-903172207589090 TABLET in 1 BOTTLE (31722-758-90) 90 tablet2023-08-04NoNoHistorical