FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
55150-176
11-digit product format
551500176
Labeler code
55150
Product ID
55150-176_4dc2ec1d-ed65-481b-bc48-fae589eae213
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA204238
Marketing category
ANDA
Marketing start
2016-07-06
Substance
GRANISETRON HYDROCHLORIDE
Active strength
4 mg/4mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRANISETRON HYDROCHLORIDE4 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii318F6L70J8
Rxcui240912, 1734399

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cfd5f35c-827b-432c-9fef-0869f8899c80Product name120260105
bd0ef290-bb63-6056-ab17-adf968a44900Product name220170616
d7be5b36-17f0-843a-22b1-df15cb96e594Product name320170616
e5d20d92-e4d9-43c9-9475-8f368311d104Product name220170501
5a6fb99e-671a-4b1d-a9dc-1e7566682136Product name120160831
5c6cdff6-4525-6e4a-2964-09019d52be11Product name120140508
ae524849-1812-2c3b-219e-58a687215e77Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-176-04Granisetron Hydrochloride1 in 1 CARTONINJECTION, SOLUTION15
55150-176-04Granisetron Hydrochloride4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-176GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]5Current NDC, Legacy NDC, 2 package rows20250507_783e9d68-2371-4fd4-8d7a-a5e36f8718d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734399granisetron HCl 1 MG in 1 ML InjectionPSN783e9d68-2371-4fd4-8d7a-a5e36f8718d05
240912granisetron HCl 1 MG/ML Injectable SolutionPSN783e9d68-2371-4fd4-8d7a-a5e36f8718d05
17343991 ML granisetron 1 MG/ML InjectionSCD783e9d68-2371-4fd4-8d7a-a5e36f8718d05
240912granisetron 1 MG/ML Injectable SolutionSCD783e9d68-2371-4fd4-8d7a-a5e36f8718d05
1734399granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML InjectionSY783e9d68-2371-4fd4-8d7a-a5e36f8718d05
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSY783e9d68-2371-4fd4-8d7a-a5e36f8718d05
1734399granisetron 1 MG per 1 ML InjectionSY783e9d68-2371-4fd4-8d7a-a5e36f8718d05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-176-04551500176041 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) / 4 mL in 1 VIAL, MULTI-DOSE2016-07-060000-00-00NoNoCurrent