NuvaRing
NUVARING (etonogestrel/ethinyl estradiol vaginal ring)
Approved
Approval ID
7e6f14df-1ce5-43fa-ad21-90bc4d74bc6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4832
Application NumberNDA021187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etonogestrel and ethinyl estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (5)
etonogestrelActive
Quantity: 11.7 mg in 1 1
Code: 304GTH6RNH
Classification: ACTIB
ethinyl estradiolActive
Quantity: 2.7 mg in 1 1
Code: 423D2T571U
Classification: ACTIM
ethylene-vinyl acetate copolymer (28% vinyl acetate)Inactive
Code: 8ILA5X28VS
Classification: IACT
ethylene-vinyl acetate copolymer (9% vinylacetate)Inactive
Code: 4OKC630HS6
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT