Etonogestrel/Ethinyl Estradiol
These highlights do not include all the information needed to use Etonogestrel/Ethinyl Estradiol Vaginal Ring safely and effectively. See full prescribing information for Etonogestrel/Ethinyl Estradiol Vaginal Ring. Etonogestrel/Ethinyl Estradiol Vaginal RingInitial U.S. Approval: 2001
Approved
Approval ID
f0d80e01-f4f5-4b1a-bc9e-50a2bd4390b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2023
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-605
Application NumberNDA021187
Product Classification
M
Marketing Category
C73605
G
Generic Name
etonogestrel and ethinyl estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (5)
ETHINYL ESTRADIOLActive
Quantity: 0.015 mg in 1 d
Code: 423D2T571U
Classification: ACTIB
ETONOGESTRELActive
Quantity: 0.12 mg in 1 d
Code: 304GTH6RNH
Classification: ACTIB
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