Tyblume
These highlights do not include all the information needed to use TYBLUME safely and effectively. See full prescribing information for TYBLUME. TYBLUME (levonorgestrel and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1968 (norgestrel and ethinyl estradiol)
Approved
Approval ID
b2482d51-d606-4aaa-8af4-19e4fe2f8872
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 12, 2023
Manufacturers
FDA
Exeltis USA, Inc.
DUNS: 071170534
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levonorgestrel and Ethinyl Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0642-7471
Application NumberNDA209405
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levonorgestrel and Ethinyl Estradiol
Product Specifications
Effective DateFebruary 12, 2023
FDA Product Classification