Granisetron

Product NDC
63323-319
Requested package NDC
63323-319-04
11-digit product format
633230319
Labeler code
63323
Product ID
63323-319_fd73c3f4-aa7d-4c2f-ab74-1883910ea086
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GRANISETRON HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA078090
Marketing category
ANDA
Marketing start
2009-11-20
Marketing end
2024-05-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63323-31963323-319-04DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A078090-001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078090-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078090-001GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTIONAP2008-06-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078090-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078090-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078090-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078090-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078090-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078090-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078090-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078090-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078090-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078090-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078090-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078090-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078090-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078090-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078090-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078090-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078090-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078090-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078090-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078090-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078090-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078090-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078090-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078090-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078090-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078090-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078090-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078090-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078090-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078090-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078090-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078090-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078090-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078090-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078090-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078090-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078090-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078090-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078090-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078090-001AP1e64feba35796…

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
63323-319-04Granisetron4 mL in 1 VIALINJECTION, SOLUTION49
63323-319-04Granisetron1 in 1 BOXINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-319-04ML - Milliliter63323-3196a46add5-2375-47f8-9d9e-2881da372f4312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-319GRANISETRON (GRANISETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Legacy NDC, 2 package rows20221221_dddc8714-383f-4bc5-a468-ae89dbc802b4.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
GranisetronGRANISETRON HYDROCHLORIDEFresenius Kabi USA, LLCdddc8714-383f-4bc5-a468-ae89dbc802b42022-11-15Warnings, Adverse reactionsExact identifier
ndc (package): 63323-319-04
ndc (product): 63323-319
ndc11 (package): 63323031904

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543218granisetron HCl 0.1 MG in 1 ML InjectionPSNdddc8714-383f-4bc5-a468-ae89dbc802b49
1734399granisetron HCl 1 MG in 1 ML InjectionPSNdddc8714-383f-4bc5-a468-ae89dbc802b49
240912granisetron HCl 1 MG/ML Injectable SolutionPSNdddc8714-383f-4bc5-a468-ae89dbc802b49
5432181 ML granisetron 0.1 MG/ML InjectionSCDdddc8714-383f-4bc5-a468-ae89dbc802b49
17343991 ML granisetron 1 MG/ML InjectionSCDdddc8714-383f-4bc5-a468-ae89dbc802b49
240912granisetron 1 MG/ML Injectable SolutionSCDdddc8714-383f-4bc5-a468-ae89dbc802b49
543218granisetron 0.1 MG per 1 ML InjectionSYdddc8714-383f-4bc5-a468-ae89dbc802b49
543218granisetron 0.1 MG/ML (as granisetron HCl 0.112 MG/ML) InjectionSYdddc8714-383f-4bc5-a468-ae89dbc802b49
1734399granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML InjectionSYdddc8714-383f-4bc5-a468-ae89dbc802b49
240912granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable SolutionSYdddc8714-383f-4bc5-a468-ae89dbc802b49
1734399granisetron 1 MG per 1 ML InjectionSYdddc8714-383f-4bc5-a468-ae89dbc802b49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-319-04633230319041 VIAL in 1 BOX (63323-319-04) > 4 mL in 1 VIAL1 vial2009-11-202024-05-31NoNoCurrent