FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
67457-863
11-digit product format
674570863
Labeler code
67457
Product ID
67457-863_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 HYDROCHLORIDE1 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-863-01Granisetron Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION14
67457-863-01Granisetron Hydrochloride1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-863-01ML - Milliliter67457-8633d0af180-771d-4b79-977d-35682336bef412018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-863GRANISETRON 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-863-01674570863011 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIAL1 vial2018-03-210000-00-00NoNoCurrent