FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
77771-121
11-digit product format
777710121
Labeler code
77771
Product ID
77771-121_09ac9273-240e-b149-e063-6394a90a20cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RADHA PHARMACEUTICALS, INC.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2023-02-20
Substance
CLOPIDOGREL BISULFATE
Active strength
300 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 BISULFATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362, 749196

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
77771-121-05Clopidogrel bisulfate500 in 1 BOTTLETABLET, FILM COATED5002
77771-121-30Clopidogrel bisulfate30 in 1 BOTTLETABLET, FILM COATED302
77771-121-90Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-121CLOPIDOGREL BISULFATE TABLET, FILM COATED [RADHA PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20231109_16aef4f6-6b90-4d5f-9e07-c9927adf3841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN16aef4f6-6b90-4d5f-9e07-c9927adf38412
309362clopidogrel 75 MG Oral TabletPSN16aef4f6-6b90-4d5f-9e07-c9927adf38412
749196clopidogrel 300 MG Oral TabletSCD16aef4f6-6b90-4d5f-9e07-c9927adf38412
309362clopidogrel 75 MG Oral TabletSCD16aef4f6-6b90-4d5f-9e07-c9927adf38412
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY16aef4f6-6b90-4d5f-9e07-c9927adf38412
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY16aef4f6-6b90-4d5f-9e07-c9927adf38412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
77771-121-0577771012105500 TABLET, FILM COATED in 1 BOTTLE (77771-121-05) 2023-02-20NoNoCurrent
77771-121-307777101213030 TABLET, FILM COATED in 1 BOTTLE (77771-121-30) 2023-02-20NoNoCurrent
77771-121-907777101219090 TABLET, FILM COATED in 1 BOTTLE (77771-121-90) 2023-02-20NoNoCurrent