xulane

Generic: norelgestromin and ethinyl estradiol

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name xulane
Generic Name norelgestromin and ethinyl estradiol
Labeler a-s medication solutions
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

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

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1683
Product ID 50090-1683_ebc72113-be27-4819-9f7d-3ba574452d8e
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 500901683
Hyphenated Format 50090-1683

Supplemental Identifiers

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

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
  • 3 POUCH in 1 CARTON (50090-1683-0) / 1 d in 1 POUCH
source: ndc

Packages (1)

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

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": "ebc72113-be27-4819-9f7d-3ba574452d8e", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "R0TAY3X631"], "rxcui": ["1534809", "1536586"], "spl_set_id": ["adcf17ef-e60b-48a4-9478-3998dab2bbbd"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (50090-1683-0)  / 1 d in 1 POUCH", "package_ndc": "50090-1683-0", "marketing_start_date": "20150206"}], "brand_name": "XULANE", "product_id": "50090-1683_ebc72113-be27-4819-9f7d-3ba574452d8e", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50090-1683", "generic_name": "norelgestromin and ethinyl estradiol", "labeler_name": "A-S Medication Solutions", "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"}