Norethindrone
Norethindrone Tablets USP, 0.35 mg
Approved
Approval ID
fb84b86e-5f1f-4c17-8b69-ff695c5faf55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-748
Application NumberANDA091209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
NORETHINDRONEActive
Quantity: 0.35 mg in 1 1
Code: T18F433X4S
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT