FDA.reportPublic FDA data

Gemcitabine

Product NDC
71288-117
11-digit product format
712880117
Labeler code
71288
Product ID
71288-117_be3f7738-022f-4b20-94f3-40f5337997c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemcitabine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212129
Marketing category
ANDA
Marketing start
2020-12-11
Substance
GEMCITABINE HYDROCHLORIDE
Active strength
38 mg/mL
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 HYDROCHLORIDE38 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU347PV74IL
Rxcui1720960, 1720975, 1720977

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
71288-117-06Gemcitabine1 in 1 CARTONINJECTION, SOLUTION17
71288-117-06Gemcitabine5.26 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5.267
71288-117-28Gemcitabine26.3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26.37
71288-117-28Gemcitabine1 in 1 CARTONINJECTION, SOLUTION17
71288-117-54Gemcitabine52.6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52.67
71288-117-54Gemcitabine1 in 1 CARTONINJECTION, SOLUTION17
71288-117-91Gemcitabine5.26 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5.261
71288-117-91Gemcitabine1 in 1 CARTONINJECTION, SOLUTION11
71288-117-92Gemcitabine1 in 1 CARTONINJECTION, SOLUTION11
71288-117-92Gemcitabine26.3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26.31
71288-117-93Gemcitabine52.6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52.61
71288-117-93Gemcitabine1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-117GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 6 package rows20240925_73ae04d8-38f9-4d3d-b0c2-71d22af1fc86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720960gemcitabine 1 GM in 26.3 ML InjectionPSN73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720975gemcitabine 2 GM in 52.6 ML InjectionPSN73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720977gemcitabine 200 MG in 5.26 ML InjectionPSN73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
172096026.3 ML gemcitabine 38 MG/ML InjectionSCD73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
17209775.26 ML gemcitabine 38 MG/ML InjectionSCD73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
172097552.6 ML gemcitabine 38 MG/ML InjectionSCD73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720960gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML InjectionSY73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720975gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML InjectionSY73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720977gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML InjectionSY73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720960gemcitabine 1 GM per 26.3 ML InjectionSY73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720975gemcitabine 2 GM per 52.6 ML InjectionSY73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720977gemcitabine 200 MG per 5.26 ML InjectionSY73ae04d8-38f9-4d3d-b0c2-71d22af1fc867
1720960gemcitabine 1 GM in 26.3 ML InjectionPSNc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720975gemcitabine 2 GM in 52.6 ML InjectionPSNc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720977gemcitabine 200 MG in 5.26 ML InjectionPSNc0b1b715-9ff8-43ca-9e49-465f1f3800841
172096026.3 ML gemcitabine 38 MG/ML InjectionSCDc0b1b715-9ff8-43ca-9e49-465f1f3800841
17209775.26 ML gemcitabine 38 MG/ML InjectionSCDc0b1b715-9ff8-43ca-9e49-465f1f3800841
172097552.6 ML gemcitabine 38 MG/ML InjectionSCDc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720960gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML InjectionSYc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720975gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML InjectionSYc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720977gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML InjectionSYc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720960gemcitabine 1 GM per 26.3 ML InjectionSYc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720975gemcitabine 2 GM per 52.6 ML InjectionSYc0b1b715-9ff8-43ca-9e49-465f1f3800841
1720977gemcitabine 200 MG per 5.26 ML InjectionSYc0b1b715-9ff8-43ca-9e49-465f1f3800841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-117-06712880117061 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06) / 5.26 mL in 1 VIAL, SINGLE-DOSE2020-12-110000-00-00NoNoCurrent
71288-117-28712880117281 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-28) / 26.3 mL in 1 VIAL, SINGLE-DOSE2020-12-110000-00-00NoNoCurrent
71288-117-54712880117541 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54) / 52.6 mL in 1 VIAL, SINGLE-DOSE2020-12-110000-00-00NoNoCurrent
71288-117-91712880117911 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE2020-12-11NoNoCurrent
71288-117-92712880117921 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE2020-12-11NoNoCurrent
71288-117-93712880117931 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE2020-12-11NoNoCurrent