NDC Code 69844-036-02 - Clopidogrel

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOPIDOGREL BISULFATE(UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)	CLOPIDOGREL	75 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIACETIN(UNII: XHX3C3X673)
CORN OIL(UNII: 8470G57WFM)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69844-036-01	30 in 1 BOTTLE Type 0: Not a Combination Product	04/06/2020
2	NDC:69844-036-02	90 in 1 BOTTLE Type 0: Not a Combination Product	04/06/2020
3	NDC:69844-036-03	500 in 1 BOTTLE Type 0: Not a Combination Product	04/06/2020
4	NDC:69844-036-04	1000 in 1 BOTTLE Type 0: Not a Combination Product	04/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204359	04/06/2020

LABELER - Graviti Pharmaceuticals Private Limited(650884781)

REGISTRANT - Graviti Pharmaceuticals Private Limited(650884781)

Establishment
Name	Address	ID/FEI	Business Operations
Graviti Pharmaceuticals Private Limited		650884781	manufacture(69844-036), analysis(69844-036)

NDC 69844-036-02
API & Excipient Details