Camila
Approved
Approval ID
b6ae15fd-6be0-48c6-8f8d-793fba0dbc87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2010
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 Code54868-4814
Application NumberANDA076177
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2010
FDA Product Classification
INGREDIENTS (7)
NORETHINDRONEActive
Quantity: 0.35 mg in 1 1
Code: T18F433X4S
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT