Granisetron Hydrochloride

Product NDC: 67877-184
11-digit product format: 678770184
Labeler code: 67877
Product ID: 67877-184_de33da5e-1833-4875-915c-578380409b54
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Granisetron Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA078969
Marketing category: ANDA
Marketing start: 2010-01-01
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67877-184		I	Inactivated by FDA	2026-08-17
excluded package	package	67877-184	67877-184-02	I	Inactivated by FDA	2026-08-17
excluded package	package	67877-184	67877-184-20	I	Inactivated by FDA	2026-08-17

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 2 · 66 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 package	package	67877-184-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67877-184-20	`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 package	package	67877-184-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67877-184-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67877-184-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67877-184-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67877-184-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67877-184-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67877-184-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67877-184-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67877-184-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67877-184-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67877-184-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67877-184-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67877-184-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67877-184-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67877-184-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67877-184-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67877-184-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67877-184-20	`e2bbac7714bc…`	`27bdfed8d636…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078969-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078969-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078969-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078969-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078969-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078969-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078969-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078969-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078969-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078969-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078969-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078969-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078969-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078969-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078969-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078969-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078969-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078969-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078969-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078969-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078969-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078969-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078969-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078969-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078969-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078969-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078969-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078969-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078969-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078969-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078969-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078969-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078969-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078969-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078969-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078969-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078969-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078969-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078969-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078969-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfd5f35c-827b-432c-9fef-0869f8899c80	Product name	1	20260105
bd0ef290-bb63-6056-ab17-adf968a44900	Product name	2	20170616
d7be5b36-17f0-843a-22b1-df15cb96e594	Product name	3	20170616
e5d20d92-e4d9-43c9-9475-8f368311d104	Product name	2	20170501
5a6fb99e-671a-4b1d-a9dc-1e7566682136	Product name	1	20160831
5c6cdff6-4525-6e4a-2964-09019d52be11	Product name	1	20140508
ae524849-1812-2c3b-219e-58a687215e77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67877-184-02	2019-10-29	C162847	48780-1	960f7f55-c42e-8e05-e053-dbdaa90a074a	Granisetron hydrochloride tablets
67877-184-20	2019-10-29	C162847	48780-1	960f7f55-c42e-8e05-e053-dbdaa90a074a	Granisetron hydrochloride tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-184-02	Granisetron Hydrochloride	2 in 1 BLISTER PACK	TABLET	2		4
67877-184-20	Granisetron Hydrochloride	20 in 1 BLISTER PACK	TABLET	20		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-184-02	EA - Each	67877-184	a337f924-e914-4f2a-a703-d849103dfe3c	1	2012-07-24
67877-184-20	EA - Each	67877-184	e639ddb2-8895-4d45-a52d-d57e8372300d	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 [ASCEND LABORATORIES, LLC]	4
GRANISETRON	ACTIVE MOIETY	WZG3J2MCOL	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-184	GRANISETRON HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]	4	Legacy NDC, 2 package rows	20110323_65d31bc7-c6a6-4515-8e3a-93e0754540b2.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	df4b6775-4337-41e0-815a-b064d98c3fe1	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078969 application number: ANDA078969
Granisetron hydrochloride	GRANISETRON HYDROCHLORIDE	Natco Pharma Limited	d2be8de3-04fe-4e92-82b4-98d749b89596	2019-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078969 application number: ANDA078969

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310599	granisetron HCl 1 MG Oral Tablet	PSN	65d31bc7-c6a6-4515-8e3a-93e0754540b2	4
310599	granisetron 1 MG Oral Tablet	SCD	65d31bc7-c6a6-4515-8e3a-93e0754540b2	4
310599	granisetron 1 MG (granisetron hydrochloride 1.12 MG) Oral Tablet	SY	65d31bc7-c6a6-4515-8e3a-93e0754540b2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67877-184-02	67877018402	2 in 1 BLISTER PACK	Historical
67877-184-20	67877018420	20 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Granisetron hydrochloride tablets	Ascend Laboratories, LLC	2011-03-21	Human Prescription Drug Label	4