etonogestrel/ethinyl estradiol

Generic: etonogestrel and ethinyl estradiol

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name etonogestrel/ethinyl estradiol
Generic Name etonogestrel and ethinyl estradiol
Labeler a-s medication solutions
Dosage Form INSERT, EXTENDED RELEASE
Routes
VAGINAL
Active Ingredients

ethinyl estradiol .015 mg/d, etonogestrel .12 mg/d

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5959
Product ID 50090-5959_74985d3b-59fe-491b-bf40-962faa0274ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021187
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 500905959
Hyphenated Format 50090-5959

Supplemental Identifiers

UNII
423D2T571U 304GTH6RNH
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 etonogestrel/ethinyl estradiol (source: ndc)
Generic Name etonogestrel and ethinyl estradiol (source: ndc)
Application Number NDA021187 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .015 mg/d
  • .12 mg/d
source: ndc
Packaging
  • 1 POUCH in 1 BOX (50090-5959-0) / 1 d in 1 POUCH
source: ndc

Packages (1)

50090-5959-0 1 POUCH in 1 BOX (50090-5959-0) / 1 d in 1 POUCH

Ingredients (2)

ethinyl estradiol (.015 mg/d) etonogestrel (.12 mg/d)

Linked Drug Pages (1)

Etonogestrel/Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "74985d3b-59fe-491b-bf40-962faa0274ab", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "304GTH6RNH"], "spl_set_id": ["fcf9da2a-bb91-4697-bfaa-c9d58855e275"], "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": "1 POUCH in 1 BOX (50090-5959-0)  / 1 d in 1 POUCH", "package_ndc": "50090-5959-0", "marketing_start_date": "20220407"}], "brand_name": "Etonogestrel/Ethinyl Estradiol", "product_id": "50090-5959_74985d3b-59fe-491b-bf40-962faa0274ab", "dosage_form": "INSERT, EXTENDED RELEASE", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50090-5959", "generic_name": "etonogestrel and ethinyl estradiol", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etonogestrel/Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".015 mg/d"}, {"name": "ETONOGESTREL", "strength": ".12 mg/d"}], "application_number": "NDA021187", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}