FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
69452-350
11-digit product format
694520350
Labeler code
69452
Product ID
69452-350_cfe3b317-aba5-46b3-83fd-df5a6d71ea76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA078678
Marketing category
ANDA
Marketing start
2022-02-28
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
69452-350-01Granisetron Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
69452-350-01Granisetron Hydrochloride2 in 1 CARTONTABLET, FILM COATED22
69452-350-11Granisetron Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
69452-350-92Granisetron Hydrochloride2 in 1 CARTONTABLET, FILM COATED22
69452-350-92Granisetron Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-350-01EA - Each69452-350316ce535-3eb4-431a-9a6c-71771f3c6af412022-05-04
69452-350-11EA - Each69452-35027216b6f-06dc-4aad-9b86-3a40c8deca5812023-05-05
69452-350-92EA - Each69452-3500a53eead-f50e-4421-83a3-3208611d8d6212023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-350GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [BIONPHARMA INC.]2Current NDC, Legacy NDC, 5 package rows20231219_50b713d3-7ca8-465a-aefa-65ddbe17b934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310599granisetron HCl 1 MG Oral TabletPSN50b713d3-7ca8-465a-aefa-65ddbe17b9342
310599granisetron 1 MG Oral TabletSCD50b713d3-7ca8-465a-aefa-65ddbe17b9342
310599granisetron 1 MG (granisetron hydrochloride 1.12 MG) Oral TabletSY50b713d3-7ca8-465a-aefa-65ddbe17b9342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-350-01694520350012 BLISTER PACK in 1 CARTON (69452-350-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2022-02-280000-00-00NoNoCurrent
69452-350-116945203501120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11) 2022-02-280000-00-00NoNoCurrent
69452-350-92694520350922 BLISTER PACK in 1 CARTON (69452-350-92) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2022-02-280000-00-00NoNoCurrent