NORETHINDRONE
Norethindrone Tablets USP, 0.35 mg
Approved
Approval ID
af851d82-b30f-463b-9dba-0437225dc1ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
norethindrone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-7292
Application NumberANDA201483
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2018
FDA Product Classification
INGREDIENTS (6)
NORETHINDRONEActive
Quantity: 0.35 mg in 1 1
Code: T18F433X4S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT