ZAFEMY
These highlights do not include all the information needed to use ZAFEMY safely and effectively. See full prescribing information for . Initial U.S. Approval: 2001
Approved
Approval ID
77230a20-4269-4abf-ae2a-ac5ccafef565
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2220
Application NumberANDA213950
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norelgestromin and Ethinyl Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (6)
NORELGESTROMINActive
Quantity: 150 ug in 1 d
Code: R0TAY3X631
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
ETHINYL ESTRADIOLActive
Quantity: 35 ug in 1 d
Code: 423D2T571U
Classification: ACTIB
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT