FDA.reportPublic FDA data

Plavix

Product NDC
63653-1171
11-digit product format
636531171
Labeler code
63653
Product ID
63653-1171_fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
Application
NDA020839
Marketing category
NDA
Marketing start
1997-11-17
Marketing end
2022-07-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63653-1171-1EA - Each63653-1171e5dbce4f-9424-48c2-8484-d0120b4e0ace12012-07-24
63653-1171-3EA - Each63653-1171e9695d67-b074-43ec-9eba-bc261598486b12012-07-24
63653-1171-5EA - Each63653-1171cd41702d-ce16-40b5-954b-0449077f687112012-07-24
63653-1171-6EA - Each63653-11716cddce4a-5b92-4e4d-a94c-73f91f3916bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clopidogrel bisulfateACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
clopidogrelACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
castor oilINACTIVE INGREDIENTD5340Y2I9GPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
mannitolINACTIVE INGREDIENT3OWL53L36APLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
triacetinINACTIVE INGREDIENTXHX3C3X673PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
clopidogrel bisulfateACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
clopidogrelACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
castor oilINACTIVE INGREDIENTD5340Y2I9GPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
mannitolINACTIVE INGREDIENT3OWL53L36APLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
triacetinINACTIVE INGREDIENTXHX3C3X673PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
clopidogrel bisulfateACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STAT RX USA LLC]1
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
clopidogrelACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
clopidogrelACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CLOPIDOGRELACTIVE MOIETYA74586SNO7PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STAT RX USA LLC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
castor oilINACTIVE INGREDIENTD5340Y2I9GPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
mannitolINACTIVE INGREDIENT3OWL53L36APLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
triacetinINACTIVE INGREDIENTXHX3C3X673PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNf1d77dba-9dae-4f30-b3e3-b4898993f8653
213169Plavix 75 MG Oral TabletPSNf1d77dba-9dae-4f30-b3e3-b4898993f8653
213169clopidogrel 75 MG Oral Tablet [Plavix]SBDf1d77dba-9dae-4f30-b3e3-b4898993f8653
309362clopidogrel 75 MG Oral TabletSCDf1d77dba-9dae-4f30-b3e3-b4898993f8653
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYf1d77dba-9dae-4f30-b3e3-b4898993f8653
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSYf1d77dba-9dae-4f30-b3e3-b4898993f8653
213169Plavix 75 MG Oral TabletSYf1d77dba-9dae-4f30-b3e3-b4898993f8653
309362clopidogrel 75 MG Oral TabletPSN0005e2a8-3ab9-4173-a46f-9c53881379e22
213169Plavix 75 MG Oral TabletPSN0005e2a8-3ab9-4173-a46f-9c53881379e22
213169clopidogrel 75 MG Oral Tablet [Plavix]SBD0005e2a8-3ab9-4173-a46f-9c53881379e22
309362clopidogrel 75 MG Oral TabletSCD0005e2a8-3ab9-4173-a46f-9c53881379e22
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY0005e2a8-3ab9-4173-a46f-9c53881379e22
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSY0005e2a8-3ab9-4173-a46f-9c53881379e22
213169Plavix 75 MG Oral TabletSY0005e2a8-3ab9-4173-a46f-9c53881379e22
309362clopidogrel 75 MG Oral TabletPSN5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
309362clopidogrel 75 MG Oral TabletPSN079ed521-3ff0-47fa-86d5-a336732056cc1
309362clopidogrel 75 MG Oral TabletPSN1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG Oral TabletPSN1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG Oral TabletPSN5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
213169Plavix 75 MG Oral TabletPSN079ed521-3ff0-47fa-86d5-a336732056cc1
213169clopidogrel 75 MG Oral Tablet [Plavix]SBD1086a7b4-b89b-4bee-8120-5f752626c0461
213169clopidogrel 75 MG Oral Tablet [Plavix]SBD5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
213169clopidogrel 75 MG Oral Tablet [Plavix]SBD079ed521-3ff0-47fa-86d5-a336732056cc1
309362clopidogrel 75 MG Oral TabletSCD1086a7b4-b89b-4bee-8120-5f752626c0461
309362clopidogrel 75 MG Oral TabletSCD079ed521-3ff0-47fa-86d5-a336732056cc1
309362clopidogrel 75 MG Oral TabletSCD5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY1086a7b4-b89b-4bee-8120-5f752626c0461
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY079ed521-3ff0-47fa-86d5-a336732056cc1
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSY5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSY079ed521-3ff0-47fa-86d5-a336732056cc1
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSY1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG Oral TabletSY5a90ba32-8479-468d-b0c5-fda9a5f7d2db1
213169Plavix 75 MG Oral TabletSY1086a7b4-b89b-4bee-8120-5f752626c0461
213169Plavix 75 MG Oral TabletSY079ed521-3ff0-47fa-86d5-a336732056cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63653-1171-16365311710190 TABLET, FILM COATED in 1 BOTTLE (63653-1171-1) 1997-11-172022-07-31NoNoCurrent