Home NDC 51991-735 Granisetron Hydrochloride
Product NDC 51991-735
11-digit product format 519910735
Labeler code 51991
Product ID 51991-735_1919cca7-47e5-4474-8ad1-a49275d4f85b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Granisetron Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA078969
Marketing category ANDA
Marketing start 2009-06-22
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 A078969-001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078969-001 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 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 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 51991-735-20 Granisetron Hydrochloride 10 in 1 BLISTER PACK TABLET 10 12 51991-735-20 Granisetron Hydrochloride 2 in 1 CARTON TABLET 2 12 51991-735-32 Granisetron Hydrochloride 2 in 1 BLISTER PACK TABLET 2 12 51991-735-32 Granisetron Hydrochloride 1 in 1 CARTON TABLET 1 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GRANISETRON HYDROCHLORIDE ACTIVE INGREDIENT 318F6L70J8 GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 GRANISETRON ACTIVE MOIETY WZG3J2MCOL GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-735 GRANISETRON HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 12 Current NDC, Legacy NDC, 4 package rows 20240327_df4b6775-4337-41e0-815a-b064d98c3fe1.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 · 2 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 51991-735-20 51991073520 2 BLISTER PACK in 1 CARTON (51991-735-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2009-06-22 0000-00-00 No No Current 51991-735-32 51991073532 1 BLISTER PACK in 1 CARTON (51991-735-32) / 2 TABLET in 1 BLISTER PACK 1 blister pack 2009-06-22 0000-00-00 No No Current