Etonogestrel and Ethinyl Estradiol Vaginal
ETONOGESTREL and ETHINYL ESTRADIOL VAGINAL RING These highlights do not include all the information needed to use EnilloRing safely and effectively. See full prescribing information for EnilloRing. Initial U.S. Approval: 2001
Approved
Approval ID
05e172aa-e18a-427b-e063-6294a90ae22f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Etonogestrel and Ethinyl Estradiol Vaginal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-478
Application NumberANDA211157
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etonogestrel and Ethinyl Estradiol Vaginal
Product Specifications
Route of AdministrationVAGINAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (5)
ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE)Inactive
Code: 8ILA5X28VS
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLENE-VINYL ACETATE COPOLYMER (9% VINYLACETATE)Inactive
Code: 4OKC630HS6
Classification: IACT
ETONOGESTRELActive
Quantity: 0.12 mg in 1 d
Code: 304GTH6RNH
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 0.015 mg in 1 d
Code: 423D2T571U
Classification: ACTIB