NDC Code(s) : 69097-987-05, 69097-987-93, 69097-988-05, 69097-988-93
Packager : Cipla USA Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PirfenidonePirfenidone TABLET, COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69097-987
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIRFENIDONE(UNII: D7NLD2JX7U)
(PIRFENIDONE - UNII:D7NLD2JX7U) 		PIRFENIDONE267 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (biconvex) Size 13 mm
Flavor Imprint Code 442
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-987-0590 in 1 BOTTLE Type 0: Not a Combination Product08/02/2022
2NDC:69097-987-93270 in 1 BOTTLE Type 0: Not a Combination Product08/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212078 08/02/2022
Pirfenidone Pirfenidone TABLET, COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69097-988
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIRFENIDONE(UNII: D7NLD2JX7U)
(PIRFENIDONE - UNII:D7NLD2JX7U) 		PIRFENIDONE801 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN Score no score
Shape OVAL (biconvex) Size 20 mm
Flavor Imprint Code 443
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-988-0590 in 1 BOTTLE Type 0: Not a Combination Product08/02/2022
2NDC:69097-988-93270 in 1 BOTTLE Type 0: Not a Combination Product08/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212078 08/02/2022

LABELER - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
ScieGen Pharmaceuticals, INC. 079391286 analysis(69097-987, 69097-988), manufacture(69097-987, 69097-988)

PRINCIPAL DISPLAY PANEL

NDC 69097-987-05         Rx Only

Pirfenidone
Tablets

267 mg

90 Tablets

Cipla

267 mg

NDC 69097-987-93         Rx Only

Pirfenidone
Tablets

267 mg

270 Tablets

Cipla

267 mg

PRINCIPAL DISPLAY PANEL

NDC 69097-988-05         Rx Only

Pirfenidone
Tablets

801 mg

90 Tablets

Cipla

801 mg

NDC 69097-988-93         Rx Only

Pirfenidone
Tablets

801 mg

270 Tablets

Cipla

801 mg