Amethyst
Amethyst™ ( Levonorgestrel and Ethinyl Estradiol Tablets , USP) 90 mcg / 20 mcg Rx o nly
Approved
Approval ID
99073fe0-eac8-44dd-abe6-623fa67d9e79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2022
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
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 Code0480-3472
Application NumberANDA079218
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2023
FDA Product Classification
INGREDIENTS (7)
LEVONORGESTRELActive
Quantity: 90 ug in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 20 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT