FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
63126-333
11-digit product format
631260333
Labeler code
63126
Product ID
63126-333_49c05ce7-fd6b-4927-9e15-a0e01097d354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Yung Shin Pharmaceutical Inc. Co., Ltd.
Application
ANDA202648
Marketing category
ANDA
Marketing start
2021-07-10
Marketing end
0000-00-00
Substance
GRANISETRON HYDROCHLORIDE
Active strength
4 mg/4mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
A202648-001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29
A202648-002GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29

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 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202648-001GRANISETRON HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A202648-002GRANISETRON HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)INJECTABLE / INJECTION2020-06-29782e0a99824c…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63126-333-41631260333411 VIAL, MULTI-DOSE in 1 CASE (63126-333-41) > 4 mL in 1 VIAL, MULTI-DOSE2021-07-100000-00-00NoNoCurrent