FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
53808-1002
11-digit product format
538081002
Labeler code
53808
Product ID
53808-1002_7d66ef28-a10c-4c41-b228-ed1d6c55dfb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA076273
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1002-12020-01-31C16284748780-19d75b9d0-59b6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use clopidogrel tablets safely and effectively. See full prescribing information for clopidogrel tablets. Clopidogrel Tablets USP for oral use Initial U.S. Approval: 1997
53808-1002-22020-01-31C16284748780-19d75b9d0-59b6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use clopidogrel tablets safely and effectively. See full prescribing information for clopidogrel tablets. Clopidogrel Tablets USP for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1002-1Clopidogrel bisulfate30 in 1 BLISTER PACKTABLET, FILM COATED301
53808-1002-2Clopidogrel bisulfate60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1002CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 2 package rows20150107_8d0ed864-bbb3-4d6b-892d-64754eec1494.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN8d0ed864-bbb3-4d6b-892d-64754eec14941
309362clopidogrel 75 MG Oral TabletSCD8d0ed864-bbb3-4d6b-892d-64754eec14941
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY8d0ed864-bbb3-4d6b-892d-64754eec14941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1002-15380810020130 in 1 BLISTER PACKHistorical
53808-1002-25380810020260 in 1 BLISTER PACKHistorical