FDA.reportPublic FDA data

Gemcitabine

Product NDC
67457-616
11-digit product format
674570616
Labeler code
67457
Product ID
67457-616_93d514c4-a877-475d-91e0-9cfb232d55ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMCITABINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA205242
Marketing category
ANDA
Marketing start
2018-01-03
Substance
GEMCITABINE HYDROCHLORIDE
Active strength
200 mg/5.26mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gemcitabine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEMCITABINE HYDROCHLORIDE200 mg/5.26mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU347PV74IL
Rxcui1720960, 1720975, 1720977

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a2b7d477-0e35-4772-8a9d-99c71e3e210bProduct name220190614
4c31c9b8-06d5-4f83-9eb7-cd946af7067aProduct name520190612
a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6Product name120180829
d2980057-8cff-4896-979e-b4c394974cfdProduct name120170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-616-10Gemcitabine5.26 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5.266
67457-616-10Gemcitabine1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-616-10ML - Milliliter67457-616997d827a-9716-41a2-8095-7db2f41f6c7212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-616GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6Current NDC, Legacy NDC, 2 package rows20241127_06dd9d40-74fc-4409-93b1-a46be7126331.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720960gemcitabine 1 GM in 26.3 ML InjectionPSN06dd9d40-74fc-4409-93b1-a46be71263316
1720975gemcitabine 2 GM in 52.6 ML InjectionPSN06dd9d40-74fc-4409-93b1-a46be71263316
1720977gemcitabine 200 MG in 5.26 ML InjectionPSN06dd9d40-74fc-4409-93b1-a46be71263316
172096026.3 ML gemcitabine 38 MG/ML InjectionSCD06dd9d40-74fc-4409-93b1-a46be71263316
17209775.26 ML gemcitabine 38 MG/ML InjectionSCD06dd9d40-74fc-4409-93b1-a46be71263316
172097552.6 ML gemcitabine 38 MG/ML InjectionSCD06dd9d40-74fc-4409-93b1-a46be71263316
1720960gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML InjectionSY06dd9d40-74fc-4409-93b1-a46be71263316
1720975gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML InjectionSY06dd9d40-74fc-4409-93b1-a46be71263316
1720977gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML InjectionSY06dd9d40-74fc-4409-93b1-a46be71263316
1720960gemcitabine 1 GM per 26.3 ML InjectionSY06dd9d40-74fc-4409-93b1-a46be71263316
1720975gemcitabine 2 GM per 52.6 ML InjectionSY06dd9d40-74fc-4409-93b1-a46be71263316
1720977gemcitabine 200 MG per 5.26 ML InjectionSY06dd9d40-74fc-4409-93b1-a46be71263316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-616-10674570616101 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) / 5.26 mL in 1 VIAL, SINGLE-DOSE2018-01-030000-00-00NoNoCurrent