XULANE (Page 9 of 9)

PRINCIPAL DISPLAY PANEL – 150/35 mcg per day

NDC 0378-3340-53

Contents: 3 Transdermal Systems | Rx only

Xulane®
(norelgestromin and ethinyl
estradiol transdermal system)
150/35 mcg per day

Each 14 cm2 system contains 4.86 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP. The inactive components are crospovidone, dipropylene glycol, fluoropolymer coated polyester film, light mineral oil, non-woven polyester fabric, oleyl alcohol, polyethylene/polyester film and polyisobutene adhesive. Each patch is printed with brown ink.

This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

For Transdermal Use Only

See patient instructions. Apply immediately upon removal
from pouch. Each transdermal system is intended to be
worn 7 days as prescribed.

Package not child-resistant. Keep out of reach of
children.

Do not store unpouched. Store at 20° to 25°C
(68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

M3340:53:3C:R15

Xulane Transdermal System 150/35 mcg per day Carton
(click image for full-size original)
XULANE
norelgestromin and ethinyl estradiol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3340
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
CROSPOVIDONE (15 MPA.S AT 5%)
MINERAL OIL
OLEYL ALCOHOL
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3340-53 3 POUCH in 1 CARTON contains a POUCH (0378-3340-16)
1 NDC:0378-3340-16 1 PATCH in 1 POUCH This package is contained within the CARTON (0378-3340-53) and contains a PATCH
1 7 d in 1 PATCH This package is contained within a POUCH (0378-3340-16) and a CARTON (0378-3340-53)
2 NDC:0378-3340-32 1 POUCH in 1 CARTON contains a POUCH (0378-3340-17)
2 NDC:0378-3340-17 1 PATCH in 1 POUCH This package is contained within the CARTON (0378-3340-32) and contains a PATCH
2 7 d in 1 PATCH This package is contained within a POUCH (0378-3340-17) and a CARTON (0378-3340-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200910 04/16/2014
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 04/2020 Mylan Pharmaceuticals Inc.

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