Home NDC 63850-0005 Granisetron hydrochloride
Product NDC 63850-0005
11-digit product format 638500005
Labeler code 63850
Product ID 63850-0005_67953305-4eb0-4b00-abae-716ac25c5bf9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Granisetron hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Natco Pharma Limited
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 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A078969-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-22 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 63850-0005-1 Granisetron hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 6 63850-0005-2 Granisetron hydrochloride 2 in 1 BLISTER PACK TABLET, FILM COATED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63850-0005 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NATCO PHARMA LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20191026_d2be8de3-04fe-4e92-82b4-98d749b89596.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 Marketing start Marketing end Sample Exclude flag Status 63850-0005-1 63850000501 10 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1) 2009-06-22 0000-00-00 No No Current 63850-0005-2 63850000502 2 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2) 2009-06-22 0000-00-00 No No Current