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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-616
Application NumberANDA205242
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-617
Application NumberANDA205242
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-618
Application NumberANDA205242
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
FDA Product Classification
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