FDA.reportPublic FDA data

Gemcitabine hydrochloride

Product NDC
82511-009
11-digit product format
825110009
Labeler code
82511
Product ID
82511-009_2b407956-8a90-221c-e063-6394a90a0057
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemcitabine hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Teyro Labs Private Limited
Application
ANDA078759
Marketing category
ANDA
Marketing start
2024-08-08
Substance
GEMCITABINE HYDROCHLORIDE
Active strength
1 g/25mL
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEMCITABINE HYDROCHLORIDE1 g/25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU347PV74IL
Rxcui1719000, 1719003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a2b7d477-0e35-4772-8a9d-99c71e3e210bProduct name220190614
4c31c9b8-06d5-4f83-9eb7-cd946af7067aProduct name520190612
a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6Product name120180829
d2980057-8cff-4896-979e-b4c394974cfdProduct name120170829
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82511-009-10Gemcitabine hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
82511-009-10Gemcitabine hydrochloride25 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82511-009GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TEYRO LABS PRIVATE LIMITED]1Current NDC, 2 package rows20250110_a6ddaa2f-4c17-430f-a7cd-96b6662923f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719003gemcitabine 1 GM InjectionPSNa6ddaa2f-4c17-430f-a7cd-96b6662923f61
1719000gemcitabine 200 MG InjectionPSNa6ddaa2f-4c17-430f-a7cd-96b6662923f61
1719003gemcitabine 1000 MG InjectionSCDa6ddaa2f-4c17-430f-a7cd-96b6662923f61
1719000gemcitabine 200 MG InjectionSCDa6ddaa2f-4c17-430f-a7cd-96b6662923f61
1719003gemcitabine (as gemcitamine HCl) 1 GM InjectionSYa6ddaa2f-4c17-430f-a7cd-96b6662923f61
1719000gemcitabine (as gemcitamine HCl) 200 MG InjectionSYa6ddaa2f-4c17-430f-a7cd-96b6662923f61
1719003gemcitabine 1 GM InjectionSYa6ddaa2f-4c17-430f-a7cd-96b6662923f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82511-009-10825110009101 VIAL, SINGLE-USE in 1 CARTON (82511-009-10) / 25 mL in 1 VIAL, SINGLE-USE2024-08-08NoNoCurrent