Amethyst
Amethyst™ ( Levonorgestrel and Ethinyl Estradiol Tablets , USP 90 mcg / 20 mcg ) Rx O nly
Approved
Approval ID
a7e19182-57b5-4783-9c7f-bb83961f1803
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2021
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code52544-295
Application NumberANDA079218
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2021
FDA Product Classification
INGREDIENTS (7)
ETHINYL ESTRADIOLActive
Quantity: 20 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LEVONORGESTRELActive
Quantity: 90 ug in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT