MICRONOR
Approved
Approval ID
6fea0c04-cfbc-4bd2-8a1f-fa3d5ed2a941
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4369
Application NumberNDA016954
Product Classification
M
Marketing Category
C73594
G
Generic Name
norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2011
FDA Product Classification
INGREDIENTS (7)
NORETHINDRONEActive
Quantity: 0.35 mg in 1 1
Code: T18F433X4S
Classification: ACTIB
D&C GREEN NO. 5Inactive
Code: 8J6RDU8L9X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT