Gemcitabine
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1996
Approved
Approval ID
06dd9d40-74fc-4409-93b1-a46be7126331
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2022
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GEMCITABINE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code67457-616
Application NumberANDA205242
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
Generic NameGEMCITABINE HYDROCHLORIDE
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 200 mg in 5.26 mL
Code: U347PV74IL
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GEMCITABINE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code67457-617
Application NumberANDA205242
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
Generic NameGEMCITABINE HYDROCHLORIDE
INGREDIENTS (4)
GEMCITABINE HYDROCHLORIDEActive
Quantity: 1 g in 26.3 mL
Code: U347PV74IL
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GEMCITABINE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code67457-618
Application NumberANDA205242
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
Generic NameGEMCITABINE HYDROCHLORIDE
INGREDIENTS (4)
GEMCITABINE HYDROCHLORIDEActive
Quantity: 2 g in 52.6 mL
Code: U347PV74IL
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT