Capecitabine Tablets, 150 mg
Capecitabine Tablets, USP 150 mg and 500 mg
Approved
Approval ID
87173e7c-6e29-2e85-e053-2a91aa0ae4ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2019
Manufacturers
FDA
Prodigy Innovation, LLC.
DUNS: 080058064
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Capecitabine Tablets, 150 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70297-003
Product Classification
G
Generic Name
Capecitabine Tablets, 150 mg
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2019
FDA Product Classification
INGREDIENTS (5)
CAPECITABINEActive
Quantity: 150 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Capecitabine Tablets, 500 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70297-004
Product Classification
G
Generic Name
Capecitabine Tablets, 500 mg
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2019
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
CAPECITABINEActive
Quantity: 500 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT