Granisetron Hydrochloride

Product NDC: 16714-221
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16714-221		D	Discontinued by firm	2026-08-03
excluded product	product	16714-221		D	Discontinued by firm	2026-08-03
excluded package	package	16714-221	16714-221-01	D	Discontinued by firm	2026-08-03
excluded package	package	16714-221	16714-221-30	D	Discontinued by firm	2026-08-03
excluded package	package	16714-221	16714-221-32	D	Discontinued by firm	2026-08-03

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-221-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-221-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-221-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-221-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-221-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-221-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16714-221-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16714-221-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16714-221-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16714-221-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16714-221-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16714-221-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16714-221-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16714-221-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16714-221-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16714-221-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16714-221-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16714-221-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16714-221-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16714-221-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16714-221-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16714-221-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16714-221-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16714-221-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16714-221-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16714-221-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16714-221-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16714-221-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16714-221-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16714-221-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16714-221-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16714-221-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16714-221-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16714-221-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16714-221-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16714-221-30	`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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078678-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078678-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078678-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078678-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078678-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078678-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078678-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078678-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078678-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078678-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078678-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078678-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078678-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078678-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078678-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078678-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078678-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078678-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078678-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078678-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078678-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078678-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078678-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078678-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078678-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078678-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078678-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078678-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078678-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078678-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078678-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078678-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078678-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078678-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078678-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078678-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078678-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078678-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078678-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078678-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-221-01	EA - Each	16714-221	42e00df4-5287-41f6-845a-d7a52beee104	1	2012-07-24
16714-221-10	EA - Each	16714-221	a9d6a32a-68ff-4e43-a883-783c364bbcb5	1	2017-04-05
16714-221-12	EA - Each	16714-221	796faa2f-aab6-4dba-8a95-d8ff8f04c7ca	1	2017-04-05
16714-221-30	EA - Each	16714-221	3d157402-ebab-4884-ba47-d986865965f6	1	2012-07-24
16714-221-32	EA - Each	16714-221	0e95923e-1285-4aab-b3d8-12d16ee5735a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Bionpharma Inc.	50b713d3-7ca8-465a-aefa-65ddbe17b934	2023-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078678 application number: ANDA078678

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
318F6L70J8	GRANISETRON HYDROCHLORIDE	107007-99-8	GRANISETRON HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	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
16714-221-30	16714022130	2 BLISTER PACK in 1 CARTON (16714-221-30) > 1 TABLET, FILM COATED in 1 BLISTER PACK (16714-221-10)	2 blister pack	2008-04-29	2021-08-31	No	No	Current
16714-221-32	16714022132	2 BLISTER PACK in 1 CARTON (16714-221-32) > 10 TABLET, FILM COATED in 1 BLISTER PACK (16714-221-12)	2 blister pack	2008-04-29	2021-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Granisetron Hydrochloride	Northstar Rx LLC \| Orchid Pharma Ltd. \| Orchid Healthcare (A Division of Orchid Pharma Ltd)	2020-11-16	HUMAN PRESCRIPTION DRUG LABEL	11
Granisetron Hydrochloride	Northstar Rx LLC \| Orchid Pharma Ltd \| Orchid Healthcare (A Division of Orchid Pharma Ltd)	2020-11-16	HUMAN PRESCRIPTION DRUG LABEL	9