NDC Code(s) : 69844-036-01, 69844-036-02, 69844-036-03, 69844-036-04
Packager : Graviti Pharmaceuticals Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-036
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOPIDOGREL BISULFATE(UNII: 08I79HTP27)
(CLOPIDOGREL - UNII:A74586SNO7) 		CLOPIDOGREL75 mg
Inactive Ingredients
Ingredient Name Strength
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)
Product Characteristics
Color pink Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 111
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-036-0130 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
2NDC:69844-036-0290 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
3NDC:69844-036-03500 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
4NDC:69844-036-041000 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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)

PRINCIPAL DISPLAY PANEL

NDC 69844- 036-01

Clopidogrel Tablets, USP

75 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only

30 Tablets

Graviti Pharma

75mg