etonogestrel and ethinyl estradiol vaginal

Generic: etonogestrel and ethinyl estradiol vaginal

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etonogestrel and ethinyl estradiol vaginal
Generic Name etonogestrel and ethinyl estradiol vaginal
Labeler avkare
Dosage Form RING
Routes
VAGINAL
Active Ingredients

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

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-478
Product ID 42291-478_1cbd9870-3ef2-b5c9-e063-6394a90a2dbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211157
Listing Expiration 2026-12-31
Marketing Start 2023-09-21

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 42291478
Hyphenated Format 42291-478

Supplemental Identifiers

RxCUI
1367436
UNII
423D2T571U 304GTH6RNH
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 etonogestrel and ethinyl estradiol vaginal (source: ndc)
Generic Name etonogestrel and ethinyl estradiol vaginal (source: ndc)
Application Number ANDA211157 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .015 mg/d
  • .12 mg/d
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11)
source: ndc

Packages (1)

42291-478-03 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11)

Ingredients (2)

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

Linked Drug Pages (1)

Etonogestrel and Ethinyl Estradiol Vaginal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "1cbd9870-3ef2-b5c9-e063-6394a90a2dbd", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "304GTH6RNH"], "rxcui": ["1367436"], "spl_set_id": ["05e172aa-e18a-427b-e063-6294a90ae22f"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (42291-478-03)  / 21 d in 1 POUCH (42291-478-11)", "package_ndc": "42291-478-03", "marketing_start_date": "20230921"}], "brand_name": "Etonogestrel and Ethinyl Estradiol Vaginal", "product_id": "42291-478_1cbd9870-3ef2-b5c9-e063-6394a90a2dbd", "dosage_form": "RING", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "42291-478", "generic_name": "Etonogestrel and Ethinyl Estradiol Vaginal", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etonogestrel and Ethinyl Estradiol Vaginal", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".015 mg/d"}, {"name": "ETONOGESTREL", "strength": ".12 mg/d"}], "application_number": "ANDA211157", "marketing_category": "ANDA", "marketing_start_date": "20230921", "listing_expiration_date": "20261231"}