Home NDC 69452-350 Granisetron Hydrochloride
Product NDC 69452-350
11-digit product format 694520350
Labeler code 69452
Product ID 69452-350_cfe3b317-aba5-46b3-83fd-df5a6d71ea76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Granisetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bionpharma Inc.
Application ANDA078678
Marketing category ANDA
Marketing start 2022-02-28
Substance GRANISETRON HYDROCHLORIDE
Active strength 1 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078678-001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078678-001 AB
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 2008-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078678-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-02-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Granisetron Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GRANISETRON HYDROCHLORIDE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 318F6L70J8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310599 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-350-01 Granisetron Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 69452-350-01 Granisetron Hydrochloride 2 in 1 CARTON TABLET, FILM COATED 2 2 69452-350-11 Granisetron Hydrochloride 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 2 69452-350-92 Granisetron Hydrochloride 2 in 1 CARTON TABLET, FILM COATED 2 2 69452-350-92 Granisetron Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-350 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [BIONPHARMA INC.] 2 Current NDC, Legacy NDC, 5 package rows 20231219_50b713d3-7ca8-465a-aefa-65ddbe17b934.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69452-350-01 69452035001 2 BLISTER PACK in 1 CARTON (69452-350-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2022-02-28 0000-00-00 No No Current 69452-350-11 69452035011 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11) 2022-02-28 0000-00-00 No No Current 69452-350-92 69452035092 2 BLISTER PACK in 1 CARTON (69452-350-92) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2022-02-28 0000-00-00 No No Current