NDC Code(s) : 69844-008-01, 69844-008-02, 69844-008-03, 69844-009-01, 69844-009-02, 69844-009-03
Packager : Graviti Pharmaceuticals Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fenofibrate fenofibrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRATE54 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE K30(UNII: U725QWY32X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color yellow (film coated) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 201
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-008-0130 in 1 BOTTLE Type 0: Not a Combination Product17/08/2018
2NDC:69844-008-0290 in 1 BOTTLE Type 0: Not a Combination Product17/08/2018
3NDC:69844-008-031000 in 1 BOTTLE Type 0: Not a Combination Product17/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210606 08/17/2018
Fenofibrate fenofibrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRATE160 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE K30(UNII: U725QWY32X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color white (film coated) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 161
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-009-0130 in 1 BOTTLE Type 0: Not a Combination Product17/08/2018
2NDC:69844-009-0290 in 1 BOTTLE Type 0: Not a Combination Product17/08/2018
3NDC:69844-009-031000 in 1 BOTTLE Type 0: Not a Combination Product17/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210606 08/17/2018

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(69844-008, 69844-009), analysis(69844-008, 69844-009)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 54 mg Tablet Bottle Label

NDC 69844-008-01

30 Tablets

Rx only

Fenofibrate Tablets USP

54 mg

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

PRINCIPAL DISPLAY PANEL - 54 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 160 mg Tablet Bottle Label

NDC 69844-009-01

30 Tablets

Rx only

Fenofibrate Tablets USP

160 mg

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

PRINCIPAL DISPLAY PANEL - 54 mg Tablet Bottle Label