FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
0143-9744
11-digit product format
001439744
Labeler code
0143
Product ID
0143-9744_3b366664-32e3-4d5c-b75c-0b764ffa31f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078629
Marketing category
ANDA
Marketing start
2009-12-23
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
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 HYDROCHLORIDE1 mg/mL

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
0143-9744-01Granisetron Hydrochloride1 mL in 1 VIAL, SINGLE-USEINJECTION111
0143-9744-10Granisetron Hydrochloride10 in 1 PACKAGEINJECTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9744-01ML - Milliliter0143-9744e25f6817-7e99-4cb7-9bea-615a68b5284a12015-11-12
0143-9744-10ML - Milliliter0143-974421af7231-d490-4273-b57e-d16ace69261b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRANISETRON HYDROCHLORIDEACTIVE INGREDIENT318F6L70J8GRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
GRANISETRONACTIVE MOIETYWZG3J2MCOLGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7
WATERINACTIVE INGREDIENT059QF0KO0RGRANISETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9744GRANISETRON HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 2 package rows20240105_e07862df-f324-4575-a1ef-f7e1cbab4c7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734399granisetron HCl 1 MG in 1 ML InjectionPSNe07862df-f324-4575-a1ef-f7e1cbab4c7a11
240912granisetron HCl 1 MG/ML Injectable SolutionPSNe07862df-f324-4575-a1ef-f7e1cbab4c7a11
17343991 ML granisetron 1 MG/ML InjectionSCDe07862df-f324-4575-a1ef-f7e1cbab4c7a11
240912granisetron 1 MG/ML Injectable SolutionSCDe07862df-f324-4575-a1ef-f7e1cbab4c7a11
1734399granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML InjectionSYe07862df-f324-4575-a1ef-f7e1cbab4c7a11
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSYe07862df-f324-4575-a1ef-f7e1cbab4c7a11
1734399granisetron 1 MG per 1 ML InjectionSYe07862df-f324-4575-a1ef-f7e1cbab4c7a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9744-01001439744011 mL in 1 VIAL, SINGLE-USE1 mlHistorical
0143-9744-100014397441010 VIAL, SINGLE-USE in 1 PACKAGE (0143-9744-10) / 1 mL in 1 VIAL, SINGLE-USE (0143-9744-01) 2009-12-230000-00-00NoNoCurrent