Clopidogrel

Product NDC
16729-218
11-digit product format
167290218
Labeler code
16729
Product ID
16729-218_d481c0f7-ad3d-c647-e053-2a95a90ac06c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202925
Marketing category
ANDA
Marketing start
2013-11-21
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-218-10EA - Each16729-2189d2044da-f0f5-4371-9890-e9094c10d62912013-08-02
16729-218-15EA - Each16729-2184b2fad7a-5936-4a05-ae67-b8db635edb7512013-08-02
16729-218-16EA - Each16729-218ae03e2dc-4d71-4c23-98ce-a4a78e86817d12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL (CLOPIDOGREL BISULPHATE) 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 TabletPSN598e28ee-0a2a-3ccc-e053-2991aa0a0a561
309362clopidogrel 75 MG Oral TabletPSNe2b2cc16-c33c-4b04-bf2d-6bd59a71df011
309362clopidogrel 75 MG Oral TabletPSNe64dfbbc-810a-662a-e053-2995a90abb421
309362clopidogrel 75 MG Oral TabletSCD598e28ee-0a2a-3ccc-e053-2991aa0a0a561
309362clopidogrel 75 MG Oral TabletSCDe2b2cc16-c33c-4b04-bf2d-6bd59a71df011
309362clopidogrel 75 MG Oral TabletSCDe64dfbbc-810a-662a-e053-2995a90abb421
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY598e28ee-0a2a-3ccc-e053-2991aa0a0a561
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYe2b2cc16-c33c-4b04-bf2d-6bd59a71df011
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYe64dfbbc-810a-662a-e053-2995a90abb421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-218-101672902181030 TABLET, FILM COATED in 1 BOTTLE (16729-218-10) 2014-01-280000-00-00NoNoCurrent
16729-218-151672902181590 TABLET, FILM COATED in 1 BOTTLE (16729-218-15) 2013-11-210000-00-00NoNoCurrent
16729-218-1616729021816500 TABLET, FILM COATED in 1 BOTTLE (16729-218-16) 2014-01-210000-00-00NoNoCurrent