Affodel
Affodel (Norethindrone 0.35 mg tablets USP) Rx only Revised: September 2022
Approved
Approval ID
8ec64ec8-fbc9-440d-9838-654a605d57da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2022
Manufacturers
FDA
Naari Pte. Limited
DUNS: 659345996
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 Code79929-015
Application NumberANDA206807
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NORETHINDRONEActive
Quantity: 0.35 mg in 1 1
Code: T18F433X4S
Classification: ACTIB