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NuvaRing

These highlights do not include all the information needed to use NuvaRing safely and effectively. See full prescribing information for NuvaRing. NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)Initial U.S. Approval: 2001

Approved
Approval ID

55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2023

Manufacturers
FDA

Organon LLC

DUNS: 117494753

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 Code78206-146
Application NumberNDA021187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etonogestrel and ethinyl estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 9, 2023
FDA Product Classification

INGREDIENTS (5)

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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE)Inactive
Code: 8ILA5X28VS
Classification: IACT
ETHYLENE-VINYL ACETATE COPOLYMER (9% VINYLACETATE)Inactive
Code: 4OKC630HS6
Classification: IACT

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