Etonogestrel and Ethinyl Estradiol Vaginal Ring
Initial U.S. Approval: 2001
Approved
Approval ID
1488f5ae-3b34-fcd7-6049-215929b1d324
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2023
Manufacturers
FDA
Northstar Rx LLC
DUNS: 830546433
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 Ring
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-029
Application NumberANDA211157
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etonogestrel and Ethinyl Estradiol Vaginal Ring
Product Specifications
Route of AdministrationVAGINAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (5)
Ethinyl EstradiolActive
Quantity: 0.015 mg in 1 d
Code: 423D2T571U
Classification: ACTIB
Ethylene-Vinyl Acetate Copolymer (9% Vinylacetate)Inactive
Code: 4OKC630HS6
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
EtonogestrelActive
Quantity: 0.12 mg in 1 d
Code: 304GTH6RNH
Classification: ACTIB
Ethylene-Vinyl Acetate Copolymer (28% Vinyl Acetate)Inactive
Code: 8ILA5X28VS
Classification: IACT