Norethindrone
Norethindrone Tablets, USP 0.35 mg
Approved
Approval ID
0d2f8fea-3675-40d2-afd9-9fcb148dbd4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 6, 2022
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-305
Application NumberANDA091209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateApril 6, 2022
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NORETHINDRONEActive
Quantity: 0.35 mg in 1 1
Code: T18F433X4S
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT