FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219282-001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 2MG BASE/10MLSOLUTION / ORAL2025-03-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219282-001GRANISETRON HYDROCHLORIDEEQ 2MG BASE/10MLSOLUTION / ORAL2025-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219282-001GRANISETRON HYDROCHLORIDEEQ 2MG BASE/10MLSOLUTION / ORAL2025-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219282-001GRANISETRON HYDROCHLORIDEEQ 2MG BASE/10MLSOLUTION / ORAL2025-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A219282-001GRANISETRON HYDROCHLORIDEEQ 2MG BASE/10MLSOLUTION / ORAL2025-03-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219282-001GRANISETRON HYDROCHLORIDEEQ 2MG BASE/10MLSOLUTION / ORAL2025-03-17a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
318F6L70J8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251426Internal RxNorm lookup
763507Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2758eb4d-2fe0-4f74-b3f5-b4903009e97cAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GranisolGRANISETRON HYDROCHLORIDEIntra-Sana Laboratories2758eb4d-2fe0-4f74-b3f5-b4903009e97c2025-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219282
application number: ANDA219282
ndc (product): 80056-801

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 ml2025-07-04NoNoCurrent