Home NDC 42043-390 Granisetron Hydrochloride
Product NDC 42043-390
11-digit product format 420430390
Labeler code 42043
Product ID 42043-390_d3bd51f3-d9f9-462c-bd71-a8c8627bd54d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Granisetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler OrchidPharma Inc
Application ANDA078678
Marketing category ANDA
Marketing start 2016-04-12
Marketing end 0000-00-00
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 2023-12-31
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-390-20 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-390-21 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-390-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-390-20 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-390-21 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-390-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-390-20 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-390-21 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-390-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-390-20 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-390-21 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-390-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-390-20 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-390-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-390-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-390-20 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-390-21 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-390-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-390-20 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-390-21 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-390-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-390-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-390-21 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-390-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-390-20 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-390-21 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-390-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-390-21 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-390-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-390-20 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-390-21 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-390-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-390-20 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-390-21 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-390-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-390-20 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-390-21 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-390-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-390-20 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-390-21 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-390-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-390-20 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-390-21 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-390-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-390-20 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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.
FDA-Initiated Inactive NDC Indexing# 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 Units Marketing start Marketing end Sample Exclude flag Status 42043-390-02 42043039002 2 BLISTER PACK in 1 CARTON (42043-390-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42043-390-00) 2 blister pack 2016-04-12 0000-00-00 No No Current 42043-390-20 42043039020 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-390-20) 2016-04-12 0000-00-00 No No Current 42043-390-21 42043039021 2 BLISTER PACK in 1 CARTON (42043-390-21) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42043-390-40) 2 blister pack 2016-04-12 0000-00-00 No No Current