esbriet pirfenidone capsule esbriet pirfenidone tablet coated
1 INDICATIONS AND USAGE ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )
genentech, inc.
OVAL YELLOW PFD
PFD OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING ESBRIET white to off-white hard gelatin capsules contain 267 mg of
PIRFENIDONE. The cap of the capsule is printed with "PFD 267 mg" in brown ink. The capsule is supplied either in a bottle, a 14-day titration blister pack or a 4-week maintenance blister pack. ESBRIET film-coated tablets are oval, biconvex, debossed with "PFD", containing 267 mg (yellow) and 801 mg (brown)
PIRFENIDONE. The film-coated tablets are supplied in bottles. ESBRIET capsules: NDC 50242-121-01, bottle for a 30-day supply containing 270 capsules and closed with a child-resistant closure NDC 50242-121-02, 14-day titration blister pack, carton containing a total of 63 capsules in two blister cards – a Week 1 blister card containing 21 capsules (1 capsule per blister well) and a Week 2 blister card containing 42 capsules (2 capsules per blister well) NDC 50242-121-03, 4-week maintenance blister pack, carton containing a total of 252 capsules in four blister cards each with 63 capsules (3 capsules per blister well) ESBRIET film-coated tablets: NDC 50242-122-05, carton containing 3 bottles, each containing ninety 267 mg tablets (270 tablets total) with a child-resistant closure NDC 50242-122-06, carton containing 1 bottle containing 270 tablets, 267 mg each, with a child-resistant closure NDC 50242-123-01, carton containing 1 bottle containing ninety 801 mg tablets, with a child-resistant closure Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) (see USP Controlled Room Temperature). Keep the bottle tightly closed. Do not use if the seal over the bottle opening is broken or missing. Safely throw away any ESBRIET that is out of date or no longer needed.
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