Tamoxifen Citrate
Tamoxifen Citrate Tablets, USP Rx Only
Approved
Approval ID
04037219-48aa-ca18-e063-6394a90abc29
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tamoxifen Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-3494
Application NumberANDA213358
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tamoxifen Citrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2023
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TAMOXIFEN CITRATEActive
Quantity: 10 mg in 1 1
Code: 7FRV7310N6
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT