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 ID: 0378-3340_47436831-f3c9-42df-a27e-5162b7e356ad
• NDC: 0378-3340
• 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: Mylan Pharmaceuticals Inc.
• 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: 2022-12-31

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 Date: 2016-06-13
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0378-3340-53 [00378334053]

XULANE PATCH

• Marketing Category: ANDA
• Application Number: ANDA200910
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-16

NDC 0378-3340-32 [00378334032]

XULANE PATCH

• Marketing Category: ANDA
• Application Number: ANDA200910
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-13

NDC 0378-3340-17 [00378334017]

XULANE PATCH

• Marketing Category: ANDA
• Application Number: ANDA200910
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-17

NDC 0378-3340-16 [00378334016]

XULANE PATCH

• Marketing Category: ANDA
• Application Number: ANDA200910
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-16

Drug Details

Active Ingredients

Ingredient	Strength
NORELGESTROMIN	150 ug/d

OpenFDA Data

• SPL SET ID: f7848550-086a-43d8-8ae5-047f4b9e4382
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• 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