FDA.reportPublic FDA data

Granisetron Hydrochloride

Product NDC
63126-331
11-digit product format
631260331
Labeler code
63126
Product ID
63126-331_74699cec-efa2-48a0-8a6f-73cb8c981083
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Yung Shin Pharmaceutical Inc. Co., Ltd.
Application
ANDA202647
Marketing category
ANDA
Marketing start
2020-12-01
Marketing end
0000-00-00
Substance
GRANISETRON HYDROCHLORIDE
Active strength
0 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202647-001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06

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 06:07:402026-07A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-064b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202647-001GRANISETRON HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)INJECTABLE / INJECTION2020-03-06a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63126-331-15631260331155 VIAL, SINGLE-DOSE in 1 BOX (63126-331-15) > 1 mL in 1 VIAL, SINGLE-DOSE2020-12-010000-00-00YesNoCurrent