FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
67457-861
11-digit product format
674570861
Labeler code
67457
Product ID
67457-861_9baf50f5-8a78-4532-af34-57f5d0c74dae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA091136
Marketing category
ANDA
Marketing start
2018-03-21
Substance
GRANISETRON HYDROCHLORIDE
Active strength
.1 mg/mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRANISETRON HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii318F6L70J8
Rxcui240912, 543218, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67457-861-012023-01-10C16284748780-1ba0f9c33-234b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION. GRANISETRON hydrochloride injection, for intravenous use Initial U.S. Approval: 1993
67457-861-012023-01-10C16284748780-1ba0f9c33-234b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION. GRANISETRON hydrochloride injection, for intravenous use Initial U.S. Approval: 1993
67457-861-012021-01-29C16284748780-1ba0f9c33-234b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION. GRANISETRON hydrochloride injection, for intravenous use Initial U.S. Approval: 1993
67457-861-012021-01-29C16284748780-1ba0f9c33-234b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION. GRANISETRON hydrochloride injection, for intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-861-00Granisetron Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION14
67457-861-01Granisetron Hydrochloride5 in 1 CARTONINJECTION, SOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-861GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20230111_8d88adba-7f5e-4e97-84b3-6ca8ec98c023.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543218granisetron HCl 0.1 MG in 1 ML InjectionPSN8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
1734399granisetron HCl 1 MG in 1 ML InjectionPSN8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
240912granisetron HCl 1 MG/ML Injectable SolutionPSN8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
5432181 ML granisetron 0.1 MG/ML InjectionSCD8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
17343991 ML granisetron 1 MG/ML InjectionSCD8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
240912granisetron 1 MG/ML Injectable SolutionSCD8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
543218granisetron 0.1 MG per 1 ML InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
543218granisetron 0.1 MG/ML (as granisetron HCl 0.112 MG/ML) InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
1734399granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
1734399granisetron 1 MG per 1 ML InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67457-861-00674570861001 mL in 1 VIAL1 mlHistorical
67457-861-01674570861015 in 1 CARTONHistorical