FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
67877-184
11-digit product format
678770184
Labeler code
67877
Product ID
67877-184_de33da5e-1833-4875-915c-578380409b54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA078969
Marketing category
ANDA
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
GRANISETRON HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
67877-184-022019-10-29C16284748780-1960f7f55-c42e-8e05-e053-dbdaa90a074aGranisetron hydrochloride tablets
67877-184-202019-10-29C16284748780-1960f7f55-c42e-8e05-e053-dbdaa90a074aGranisetron hydrochloride tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-184-02Granisetron Hydrochloride2 in 1 BLISTER PACKTABLET24
67877-184-20Granisetron Hydrochloride20 in 1 BLISTER PACKTABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-184-02EA - Each67877-184a337f924-e914-4f2a-a703-d849103dfe3c12012-07-24
67877-184-20EA - Each67877-184e639ddb2-8895-4d45-a52d-d57e8372300d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRANISETRON HYDROCHLORIDEACTIVE INGREDIENT318F6L70J8GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
GRANISETRONACTIVE MOIETYWZG3J2MCOLGRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-184GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4Legacy NDC, 2 package rows20110323_65d31bc7-c6a6-4515-8e3a-93e0754540b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310599granisetron HCl 1 MG Oral TabletPSN65d31bc7-c6a6-4515-8e3a-93e0754540b24
310599granisetron 1 MG Oral TabletSCD65d31bc7-c6a6-4515-8e3a-93e0754540b24
310599granisetron 1 MG (granisetron hydrochloride 1.12 MG) Oral TabletSY65d31bc7-c6a6-4515-8e3a-93e0754540b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67877-184-02678770184022 in 1 BLISTER PACKHistorical
67877-184-206787701842020 in 1 BLISTER PACKHistorical