NDC 0378-3340

XULANE

Norelgestromin And Ethinyl Estradiol

XULANE is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Norelgestromin; Ethinyl Estradiol.

Product ID0378-3340_47436831-f3c9-42df-a27e-5162b7e356ad
NDC0378-3340
Product TypeHuman Prescription Drug
Proprietary NameXULANE
Generic NameNorelgestromin And Ethinyl Estradiol
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2014-04-16
Marketing CategoryANDA / ANDA
Application NumberANDA200910
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNORELGESTROMIN; ETHINYL ESTRADIOL
Active Ingredient Strength150 ug/d; ug/d
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-3340-32

1 POUCH in 1 CARTON (0378-3340-32) > 1 PATCH in 1 POUCH (0378-3340-17) > 7 d in 1 PATCH
Marketing Start Date2016-06-13
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0378-3340-53 [00378334053]

XULANE PATCH
Marketing CategoryANDA
Application NumberANDA200910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-16

NDC 0378-3340-32 [00378334032]

XULANE PATCH
Marketing CategoryANDA
Application NumberANDA200910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-13

NDC 0378-3340-17 [00378334017]

XULANE PATCH
Marketing CategoryANDA
Application NumberANDA200910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-17

NDC 0378-3340-16 [00378334016]

XULANE PATCH
Marketing CategoryANDA
Application NumberANDA200910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-16

Drug Details

Active Ingredients

IngredientStrength
NORELGESTROMIN150 ug/d

OpenFDA Data

SPL SET ID:f7848550-086a-43d8-8ae5-047f4b9e4382
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1534809
  • 1536586

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Estrogen [EPC]

    NDC Crossover Matching brand name "XULANE" or generic name "Norelgestromin And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    0378-3340XULANEnorelgestromin and ethinyl estradiol
    50090-1683XULANEnorelgestromin and ethinyl estradiol

    Trademark Results [XULANE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XULANE
    XULANE
    85753997 4560909 Live/Registered
    Mylan Pharmaceuticals, Inc.
    2012-10-15
    XULANE
    XULANE
    77809942 not registered Dead/Abandoned
    Mylan Pharmaceuticals, Inc.
    2009-08-21
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.