GRANISETRON HYDROCHLORIDE

Product NDC
55648-661
11-digit product format
556480661
Labeler code
55648
Product ID
55648-661_dae3e3e8-5de8-412f-9b98-6443c9d2edc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GRANISETRON HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WOCKHARDT LIMITED
Application
ANDA078564
Marketing category
ANDA
Marketing start
2008-06-30
Marketing end
0000-00-00
Substance
GRANISETRON HYDROCHLORIDE
Active strength
1 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-661-02GRANISETRON HYDROCHLORIDE4 mL in 1 VIAL, MULTI-DOSEINJECTION42
55648-661-02GRANISETRON HYDROCHLORIDE1 in 1 CARTONINJECTION12
55648-661-01GRANISETRON HYDROCHLORIDE5 in 1 CARTONINJECTION51
55648-661-03GRANISETRON HYDROCHLORIDE1 in 1 CARTONINJECTION11
55648-661-03GRANISETRON HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-USEINJECTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRANISETRON HYDROCHLORIDEACTIVE INGREDIENT318F6L70J8GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
GRANISETRONACTIVE MOIETYWZG3J2MCOLGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RGRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2
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
55648-661GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]2Legacy NDC, 2 package rows20120203_af68579f-c863-4535-94af-a4126b43c182.zip
55648-661GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1Legacy NDC, 3 package rows20120215_fb723c47-002e-4243-9c5e-448f5cfd6d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240912granisetron HCl 1 MG/ML Injectable SolutionPSNaf68579f-c863-4535-94af-a4126b43c1822
240912granisetron 1 MG/ML Injectable SolutionSCDaf68579f-c863-4535-94af-a4126b43c1822
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSYaf68579f-c863-4535-94af-a4126b43c1822
240912granisetron HCl 1 MG/ML Injectable SolutionPSNfb723c47-002e-4243-9c5e-448f5cfd6d681
240912granisetron 1 MG/ML Injectable SolutionSCDfb723c47-002e-4243-9c5e-448f5cfd6d681
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSYfb723c47-002e-4243-9c5e-448f5cfd6d681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55648-661-01556480661015 in 1 CARTONHistorical
55648-661-02556480661024 mL in 1 VIAL, MULTI-DOSE4 mlHistorical
55648-661-03556480661031 in 1 CARTONHistorical