Junel 1.5/30
Junel 21 Day (norethindrone acetate and ethinyl estradiol tablets, USP)Junel Fe 28 Day(norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay.
Approved
Approval ID
beb528b7-dea2-4fec-b0d4-58d4e83d746b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
norethindrone acetate and ethinyl estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6272
Application NumberANDA076381
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone acetate and ethinyl estradiol
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2012
FDA Product Classification
INGREDIENTS (10)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
NORETHINDRONE ACETATEActive
Quantity: 1.5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHINYL ESTRADIOLActive
Quantity: 30 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5935
Application NumberANDA076064
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Product Specifications
Effective DateApril 16, 2012
FDA Product Classification
norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5326
Application NumberANDA076081
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Product Specifications
Effective DateApril 16, 2012
FDA Product Classification