ZAFEMY (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

Pouch
(click image for full-size original)

Carton
(click image for full-size original)

ZAFEMY norelgestromin and ethinyl estradiol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-358
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORELGESTROMIN (NORELGESTROMIN) NORELGESTROMIN 150 ug in 1 d
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 35 ug in 1 d
Inactive Ingredients
Ingredient Name Strength
POLYBUTENE (1400 MW)
CROSPOVIDONE
OLEYL ALCOHOL
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-358-03 3 POUCH in 1 CARTON contains a POUCH (65162-358-01)
1 NDC:65162-358-01 1 PATCH in 1 POUCH This package is contained within the CARTON (65162-358-03) and contains a PATCH
1 7 d in 1 PATCH This package is contained within a POUCH (65162-358-01) and a CARTON (65162-358-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213950 06/28/2020
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 053542455 analysis (65162-358), label (65162-358), manufacture (65162-358), pack (65162-358)

Revised: 04/2022 Amneal Pharmaceuticals LLC

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