NDC 50090-1683

XULANE

Norelgestromin And Ethinyl Estradiol

XULANE is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Norelgestromin; Ethinyl Estradiol.

• Product ID: 50090-1683_32a201fa-279f-48c8-8f04-1a7809e63e9d
• NDC: 50090-1683
• Product Type: Human Prescription Drug
• Proprietary Name: XULANE
• Generic Name: Norelgestromin And Ethinyl Estradiol
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2014-04-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200910
• Labeler Name: A-S Medication Solutions
• Substance Name: NORELGESTROMIN; ETHINYL ESTRADIOL
• Active Ingredient Strength: 150 ug/d; ug/d
• Pharm Classes: Progesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-1683-0

3 POUCH in 1 CARTON (50090-1683-0) > 1 d in 1 POUCH

• Marketing Start Date: 2015-02-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1683-0 [50090168300]

XULANE PATCH

• Marketing Category: ANDA
• Application Number: ANDA200910
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-06
• Marketing End Date: 2019-11-30

Drug Details

Active Ingredients

Ingredient	Strength
NORELGESTROMIN	150 ug/d

OpenFDA Data

• SPL SET ID: adcf17ef-e60b-48a4-9478-3998dab2bbbd
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 423D2T571U
  • R0TAY3X631
• 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"

NDC	Brand Name	Generic Name
0378-3340	XULANE	norelgestromin and ethinyl estradiol
50090-1683	XULANE	norelgestromin and ethinyl estradiol