FDA.reportPublic FDA data

GRANISETRON HYDROCHLORIDE

Product NDC
55648-662
11-digit product format
556480662
Labeler code
55648
Product ID
55648-662_ac38ecc1-4f9d-4c72-88d5-c3caf3bf2b51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GRANISETRON HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WOCKHARDT LIMITED
Application
ANDA078566
Marketing category
ANDA
Marketing start
2008-03-03
Marketing end
0000-00-00
Substance
GRANISETRON HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
55648-662-012020-01-31C16284748780-19d75b9d1-0cea-f424-e053-dadaa90a57ceThese 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, USP, for intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-662-01GRANISETRON HYDROCHLORIDE5 in 1 CARTONINJECTION51
55648-662-02GRANISETRON HYDROCHLORIDE1 in 1 CARTONINJECTION11
55648-662-02GRANISETRON HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-USEINJECTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRANISETRON HYDROCHLORIDEACTIVE INGREDIENT318F6L70J8GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
GRANISETRONACTIVE MOIETYWZG3J2MCOLGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
WATERINACTIVE INGREDIENT059QF0KO0RGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-662GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1Legacy NDC, 3 package rows20111130_a43da9a3-1997-40d9-8622-97490a5c0642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543218granisetron HCl 0.1 MG in 1 ML InjectionPSNa43da9a3-1997-40d9-8622-97490a5c06421
5432181 ML granisetron 0.1 MG/ML InjectionSCDa43da9a3-1997-40d9-8622-97490a5c06421
543218granisetron 0.1 MG per 1 ML InjectionSYa43da9a3-1997-40d9-8622-97490a5c06421
543218granisetron 0.1 MG/ML (as granisetron HCl 0.112 MG/ML) InjectionSYa43da9a3-1997-40d9-8622-97490a5c06421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-662-01556480662015 in 1 CARTONHistorical
55648-662-02556480662021 in 1 CARTONHistorical