Granisetron Hydrochloride

Product NDC
0143-9745
11-digit product format
001439745
Labeler code
0143
Product ID
0143-9745_3b366664-32e3-4d5c-b75c-0b764ffa31f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078629
Marketing category
ANDA
Marketing start
2009-12-23
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078629-001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23
A078629-002GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078629-001AP
A078629-002AP

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 06:07:402026-07A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078629-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078629-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2009-12-23bb7c543d1eb4…

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 06:07:402026-07A078629-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078629-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078629-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078629-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078629-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078629-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078629-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078629-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078629-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078629-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078629-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078629-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078629-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078629-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078629-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078629-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078629-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078629-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078629-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078629-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078629-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078629-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078629-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078629-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078629-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078629-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078629-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078629-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078629-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078629-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078629-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078629-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078629-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078629-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078629-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078629-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078629-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078629-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078629-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078629-002AP1bb7c543d1eb4…

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/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240912Internal 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
e07862df-f324-4575-a1ef-f7e1cbab4c7aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9745-01Granisetron Hydrochloride4 mL in 1 VIAL, MULTI-DOSEINJECTION411
0143-9745-05Granisetron Hydrochloride5 in 1 CARTONINJECTION511
0143-9745-10Granisetron Hydrochloride10 in 1 CARTONINJECTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9745-01ML - Milliliter0143-9745c9386ae9-cd01-46c1-8cc4-d2d34a882c5c12015-11-12
0143-9745-05ML - Milliliter0143-974577d92a76-ffe4-4176-8ccc-dba71752021812014-10-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9745GRANISETRON HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 3 package rows20240105_e07862df-f324-4575-a1ef-f7e1cbab4c7a.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 HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e07862df-f324-4575-a1ef-f7e1cbab4c7a2024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078629
application number: ANDA078629
ndc (product): 0143-9745

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734399granisetron HCl 1 MG in 1 ML InjectionPSNe07862df-f324-4575-a1ef-f7e1cbab4c7a11
240912granisetron HCl 1 MG/ML Injectable SolutionPSNe07862df-f324-4575-a1ef-f7e1cbab4c7a11
17343991 ML granisetron 1 MG/ML InjectionSCDe07862df-f324-4575-a1ef-f7e1cbab4c7a11
240912granisetron 1 MG/ML Injectable SolutionSCDe07862df-f324-4575-a1ef-f7e1cbab4c7a11
1734399granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML InjectionSYe07862df-f324-4575-a1ef-f7e1cbab4c7a11
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSYe07862df-f324-4575-a1ef-f7e1cbab4c7a11
1734399granisetron 1 MG per 1 ML InjectionSYe07862df-f324-4575-a1ef-f7e1cbab4c7a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9745-01001439745014 mL in 1 VIAL, MULTI-DOSE4 mlHistorical
0143-9745-05001439745055 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01) 2009-12-230000-00-00NoNoCurrent
0143-9745-100014397451010 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01) 2009-12-230000-00-00NoNoCurrent