Granisetron Hydrochloride

Product NDC
67457-861
11-digit product format
674570861
Labeler code
67457
Product ID
67457-861_9baf50f5-8a78-4532-af34-57f5d0c74dae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA091136
Marketing category
ANDA
Marketing start
2018-03-21
Substance
GRANISETRON HYDROCHLORIDE
Active strength
.1 mg/mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091136-001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09
A091136-002GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091136-001AP
A091136-002AP

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091136-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091136-002GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2010-04-09bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091136-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A091136-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091136-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091136-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091136-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091136-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091136-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091136-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091136-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091136-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091136-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091136-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091136-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091136-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091136-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091136-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091136-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091136-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091136-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091136-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091136-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091136-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091136-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091136-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091136-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091136-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091136-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091136-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091136-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091136-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091136-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091136-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091136-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091136-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091136-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091136-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091136-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091136-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091136-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091136-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Granisetron Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRANISETRON HYDROCHLORIDE.1 mg/mL

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240912Internal RxNorm lookup
543218Internal RxNorm lookup
1734399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d88adba-7f5e-4e97-84b3-6ca8ec98c023Available on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-861-00Granisetron Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION14
67457-861-01Granisetron Hydrochloride5 in 1 CARTONINJECTION, SOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-861GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20230111_8d88adba-7f5e-4e97-84b3-6ca8ec98c023.zip

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
Granisetron HydrochlorideGRANISETRON HYDROCHLORIDEMylan Institutional LLC8d88adba-7f5e-4e97-84b3-6ca8ec98c0232017-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091136
application number: ANDA091136
ndc (product): 67457-861

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543218granisetron HCl 0.1 MG in 1 ML InjectionPSN8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
1734399granisetron HCl 1 MG in 1 ML InjectionPSN8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
240912granisetron HCl 1 MG/ML Injectable SolutionPSN8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
5432181 ML granisetron 0.1 MG/ML InjectionSCD8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
17343991 ML granisetron 1 MG/ML InjectionSCD8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
240912granisetron 1 MG/ML Injectable SolutionSCD8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
543218granisetron 0.1 MG per 1 ML InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
543218granisetron 0.1 MG/ML (as granisetron HCl 0.112 MG/ML) InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
1734399granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234
1734399granisetron 1 MG per 1 ML InjectionSY8d88adba-7f5e-4e97-84b3-6ca8ec98c0234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67457-861-00674570861001 mL in 1 VIAL1 mlHistorical
67457-861-01674570861015 in 1 CARTONHistorical