Pirfenidone (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 0480-3610-87
Pirfenidone Tablets
267 mg
Rx only
270 Tablets

267mg270
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0480-3611-98
Pirfenidone Tablets
801 mg
Rx only
90 Tablets

801mg90s
(click image for full-size original)
PIRFENIDONE pirfenidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-3610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIRFENIDONE (PIRFENIDONE) PIRFENIDONE 267 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 3610;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-3610-87 270 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212759 05/11/2022
PIRFENIDONE pirfenidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-3611
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIRFENIDONE (PIRFENIDONE) PIRFENIDONE 801 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color purple Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 3611;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-3611-98 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212759 05/11/2022
Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 02/2022 Teva Pharmaceuticals, Inc.

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