xulane

Generic: norelgestromin and ethinyl estradiol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name xulane
Generic Name norelgestromin and ethinyl estradiol
Labeler mylan pharmaceuticals inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

ethinyl estradiol 35 ug/d, norelgestromin 150 ug/d

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3340
Product ID 0378-3340_5cf2e689-da68-4a6a-8761-267a63244360
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200910
Listing Expiration 2026-12-31
Marketing Start 2014-04-16

Pharmacologic Class

Established (EPC)
estrogen [epc] progestin [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783340
Hyphenated Format 0378-3340

Supplemental Identifiers

RxCUI
1534809 1536586
UNII
423D2T571U R0TAY3X631
NUI
N0000175825 N0000000100 M0447349 N0000175602

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xulane (source: ndc)
Generic Name norelgestromin and ethinyl estradiol (source: ndc)
Application Number ANDA200910 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 35 ug/d
  • 150 ug/d
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (0378-3340-32) / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH
  • 3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH
source: ndc

Packages (2)

0378-3340-32 1 POUCH in 1 CARTON (0378-3340-32) / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH 0378-3340-53 3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH

Ingredients (2)

ethinyl estradiol (35 ug/d) norelgestromin (150 ug/d)

Linked Drug Pages (1)

XULANE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "5cf2e689-da68-4a6a-8761-267a63244360", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "R0TAY3X631"], "rxcui": ["1534809", "1536586"], "spl_set_id": ["f7848550-086a-43d8-8ae5-047f4b9e4382"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 POUCH in 1 CARTON (0378-3340-32)  / 1 PATCH in 1 POUCH (0378-3340-17)  / 7 d in 1 PATCH", "package_ndc": "0378-3340-32", "marketing_start_date": "20160613"}, {"sample": false, "description": "3 POUCH in 1 CARTON (0378-3340-53)  / 1 PATCH in 1 POUCH (0378-3340-16)  / 7 d in 1 PATCH", "package_ndc": "0378-3340-53", "marketing_start_date": "20140416"}], "brand_name": "XULANE", "product_id": "0378-3340_5cf2e689-da68-4a6a-8761-267a63244360", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0378-3340", "generic_name": "norelgestromin and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XULANE", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "35 ug/d"}, {"name": "NORELGESTROMIN", "strength": "150 ug/d"}], "application_number": "ANDA200910", "marketing_category": "ANDA", "marketing_start_date": "20140416", "listing_expiration_date": "20261231"}