Granisol

Product NDC
80056-801
11-digit product format
800560801
Labeler code
80056
Product ID
80056-801_30daad07-468f-c766-e063-6294a90a0019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
granisetron hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Intra-Sana Laboratories
Application
ANDA219282
Marketing category
ANDA
Marketing start
2025-07-04
Substance
GRANISETRON HYDROCHLORIDE
Active strength
2 mg/10mL
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
Granisol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRANISETRON HYDROCHLORIDE2 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii318F6L70J8
Rxcui251426, 763507

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cfd5f35c-827b-432c-9fef-0869f8899c80Product name120260105
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
bd0ef290-bb63-6056-ab17-adf968a44900Product name220170616
d7be5b36-17f0-843a-22b1-df15cb96e594Product name320170616
e5d20d92-e4d9-43c9-9475-8f368311d104Product name220170501
5a6fb99e-671a-4b1d-a9dc-1e7566682136Product name120160831
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
5c6cdff6-4525-6e4a-2964-09019d52be11Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ae524849-1812-2c3b-219e-58a687215e77Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80056-801-30Granisol30 mL in 1 BOTTLE, GLASSSOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80056-801-30ML - Milliliter80056-801379a52d4-8953-4fdc-b83d-f7704e53074312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251426granisetron 2 MG in 10 mL Oral SolutionPSN2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
763507Granisol 2 MG in 10 mL Oral SolutionPSN2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
763507granisetron 0.2 MG/ML Oral Solution [Granisol]SBD2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
251426granisetron 0.2 MG/ML Oral SolutionSCD2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
251426granisetron 0.2 MG/ML (granisetron hydrochloride 0.224 MG/ML) Oral SolutionSY2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
251426granisetron 1 MG per 5 ML Oral SolutionSY2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
763507Granisol 0.2 MG/ML (granisetron hydrochloride 0.224 MG/ML) Oral SolutionSY2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
763507Granisol 0.2 MG/ML Oral SolutionSY2758eb4d-2fe0-4f74-b3f5-b4903009e97c2
763507Granisol 2 MG per 10 ML Oral SolutionSY2758eb4d-2fe0-4f74-b3f5-b4903009e97c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80056-801-308005608013030 mL in 1 BOTTLE, GLASS (80056-801-30) 30 ml2025-07-04NoNoHistorical