norelgestromin and ethinyl estradiol
These highlights do not include all the information needed to use NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal systemInitial U.S. Approval: 2001
Approved
Approval ID
10fa1458-c8ed-4197-922a-1ba7271d2b02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
norelgestromin and ethinyl estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1190
Application NumberANDA214594
Product Classification
M
Marketing Category
C73584
G
Generic Name
norelgestromin and ethinyl estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 16, 2023
FDA Product Classification
INGREDIENTS (4)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
NORELGESTROMINActive
Quantity: 150 ug in 1 mg
Code: R0TAY3X631
Classification: ACTIB
LAURYL LACTATEInactive
Code: G5SU0BFK7O
Classification: IACT
ETHINYL ESTRADIOLActive
Quantity: 35 ug in 1 mg
Code: 423D2T571U
Classification: ACTIB