FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
55111-671
11-digit product format
551110671
Labeler code
55111
Product ID
55111-671_e74780f8-a035-e6a0-b457-c04edd4162bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA091023
Marketing category
ANDA
Marketing start
2012-05-17
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
Rxcui749196

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
55111-671-01Clopidogrel bisulfate100 in 1 BOTTLETABLET, FILM COATED10029
55111-671-05Clopidogrel bisulfate500 in 1 BOTTLETABLET, FILM COATED50029
55111-671-06Clopidogrel bisulfate6 in 1 BLISTER PACKTABLET, FILM COATED629
55111-671-30Clopidogrel bisulfate30 in 1 BOTTLETABLET, FILM COATED3029
55111-671-31Clopidogrel bisulfate5 in 1 CARTONTABLET, FILM COATED529
55111-671-48Clopidogrel bisulfate1 in 1 CARTONTABLET, FILM COATED129
55111-671-48Clopidogrel bisulfate4 in 1 BLISTER PACKTABLET, FILM COATED429
55111-671-78Clopidogrel bisulfate10 in 1 CARTONTABLET, FILM COATED1029
55111-671-79Clopidogrel bisulfate10 in 1 BLISTER PACKTABLET, FILM COATED1029
55111-671-81Clopidogrel bisulfate3 in 1 CARTONTABLET, FILM COATED329
55111-671-90Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-671-06EA - Each55111-671e3ac8211-1510-4bb4-ba99-ef936e159d5712012-07-24
55111-671-31EA - Each55111-671a0904467-bdc8-4689-b22f-c55e1923b00712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clopidogrel bisulfateACTIVE INGREDIENT08I79HTP27CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
ClopidogrelACTIVE MOIETYA74586SNO7CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
mannitolINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-671CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]29Current NDC, Legacy NDC, 11 package rows20240717_4da4da53-91ae-4d4f-145f-255c5db443a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN4da4da53-91ae-4d4f-145f-255c5db443a529
749196clopidogrel 300 MG Oral TabletSCD4da4da53-91ae-4d4f-145f-255c5db443a529
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY4da4da53-91ae-4d4f-145f-255c5db443a529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-671-0155111067101100 TABLET, FILM COATED in 1 BOTTLE (55111-671-01) 2012-05-170000-00-00NoNoCurrent
55111-671-0555111067105500 TABLET, FILM COATED in 1 BOTTLE (55111-671-05) 2012-05-170000-00-00NoNoCurrent
55111-671-06551110671066 in 1 BLISTER PACKHistorical
55111-671-305511106713030 TABLET, FILM COATED in 1 BOTTLE (55111-671-30) 2012-05-170000-00-00NoNoCurrent
55111-671-31551110671315 BLISTER PACK in 1 CARTON (55111-671-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (55111-671-06) 5 blister pack2012-05-170000-00-00NoNoCurrent
55111-671-48551110671481 BLISTER PACK in 1 CARTON (55111-671-48) / 4 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2012-05-170000-00-00NoNoCurrent
55111-671-785511106717810 BLISTER PACK in 1 CARTON (55111-671-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-671-79) 10 blister pack2012-05-170000-00-00NoNoCurrent
55111-671-795511106717910 in 1 BLISTER PACKHistorical
55111-671-81551110671813 BLISTER PACK in 1 CARTON (55111-671-81) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-671-79) 3 blister pack2012-05-170000-00-00NoNoCurrent
55111-671-905511106719090 TABLET, FILM COATED in 1 BOTTLE (55111-671-90) 2012-05-170000-00-00NoNoCurrent