Home NDC 16714-221-01 Granisetron Hydrochloride
Product NDC 16714-221
Requested package NDC 16714-221-01
11-digit product format 167140221
Labeler code 16714
Product ID 16714-221_434276c5-ae66-497a-8e30-5d079507dcfa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Granisetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northstar Rx LLC
Application ANDA078678
Marketing category ANDA
Marketing start 2008-04-29
Marketing end 2021-08-31
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GRANISETRON HYDROCHLORIDE ACTIVE INGREDIENT 318F6L70J8 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 GRANISETRON ACTIVE MOIETY WZG3J2MCOL GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 9 GRANISETRON HYDROCHLORIDE ACTIVE INGREDIENT 318F6L70J8 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7 GRANISETRON ACTIVE MOIETY WZG3J2MCOL GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GRANISETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 7
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-221-01 16714022101 20 TABLET, FILM COATED in 1 BOTTLE (16714-221-01) 2008-04-29 2021-08-31 No No Current