FDA.reportPublic FDA data

Granisetron hydrochloride

Product NDC
63850-0005
11-digit product format
638500005
Labeler code
63850
Product ID
63850-0005_67953305-4eb0-4b00-abae-716ac25c5bf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Natco Pharma Limited
Application
ANDA078969
Marketing category
ANDA
Marketing start
2009-06-22
Substance
GRANISETRON HYDROCHLORIDE
Active strength
1 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii318F6L70J8
Rxcui310599

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
63850-0005-1Granisetron hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED106
63850-0005-2Granisetron hydrochloride2 in 1 BLISTER PACKTABLET, FILM COATED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63850-0005GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NATCO PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20191026_d2be8de3-04fe-4e92-82b4-98d749b89596.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310599granisetron HCl 1 MG Oral TabletPSNd2be8de3-04fe-4e92-82b4-98d749b895966
310599granisetron 1 MG Oral TabletSCDd2be8de3-04fe-4e92-82b4-98d749b895966
310599granisetron 1 MG (granisetron hydrochloride 1.12 MG) Oral TabletSYd2be8de3-04fe-4e92-82b4-98d749b895966

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63850-0005-16385000050110 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1) 2009-06-220000-00-00NoNoCurrent
63850-0005-2638500005022 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2) 2009-06-220000-00-00NoNoCurrent