FDA.reportPublic FDA data

Gemcitabine

Product NDC
0409-0182
11-digit product format
004090182
Labeler code
0409
Product ID
0409-0182_3a284abb-8c57-47dc-a138-5a6e6ab92b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMCITABINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA200795
Marketing category
NDA
Marketing start
2011-08-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gemcitabine
Listing expiration
2027-12-31

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
0409-0182-01Gemcitabine52.6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52.628
0409-0182-01Gemcitabine1 in 1 CARTONINJECTION, SOLUTION128
0409-0182-25Gemcitabine52.6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52.610
0409-0182-25Gemcitabine1 in 1 CARTONINJECTION, SOLUTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0182GEMCITABINE INJECTION, SOLUTION [HOSPIRA, INC.]25Current NDC, Legacy NDC, 2 package rows20250121_dc02a23b-3ff9-4441-aa91-8e9e629a7315.zip
0409-0182GEMCITABINE INJECTION, SOLUTION [HOSPIRA, INC.]9Current NDC, Legacy NDC, 2 package rows20240710_e18ed1cb-7dd0-4001-bfda-17d1f4587fb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720960gemcitabine 1 GM in 26.3 ML InjectionPSNdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720975gemcitabine 2 GM in 52.6 ML InjectionPSNdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720977gemcitabine 200 MG in 5.26 ML InjectionPSNdc02a23b-3ff9-4441-aa91-8e9e629a731528
172096026.3 ML gemcitabine 38 MG/ML InjectionSCDdc02a23b-3ff9-4441-aa91-8e9e629a731528
17209775.26 ML gemcitabine 38 MG/ML InjectionSCDdc02a23b-3ff9-4441-aa91-8e9e629a731528
172097552.6 ML gemcitabine 38 MG/ML InjectionSCDdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720960gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML InjectionSYdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720975gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML InjectionSYdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720977gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML InjectionSYdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720960gemcitabine 1 GM per 26.3 ML InjectionSYdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720975gemcitabine 2 GM per 52.6 ML InjectionSYdc02a23b-3ff9-4441-aa91-8e9e629a731528
1720977gemcitabine 200 MG per 5.26 ML InjectionSYdc02a23b-3ff9-4441-aa91-8e9e629a731528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-0182-01004090182011 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-01) / 52.6 mL in 1 VIAL, SINGLE-DOSE2011-08-220000-00-00NoNoCurrent
0409-0182-25004090182251 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-25) / 52.6 mL in 1 VIAL, SINGLE-DOSE2013-07-290000-00-00NoNoCurrent