Granisetron Hydrochloride

Product NDC: 17478-546
11-digit product format: 174780546
Labeler code: 17478
Product ID: 17478-546_bd8585c7-95d2-4e0b-a0d8-1da1596340fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Granisetron Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Akorn
Application: ANDA079078
Marketing category: ANDA
Marketing start: 2009-10-01
Marketing end: 0000-00-00
Substance: GRANISETRON HYDROCHLORIDE
Active strength: 1 mg/mL
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

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	17478-546		I	Inactivated by FDA	2026-08-17
excluded package	package	17478-546	17478-546-02	I	Inactivated by FDA	2026-08-17
excluded package	package	17478-546	17478-546-05	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 1 · 45 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	17478-546-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-546-05	`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	17478-546-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-546-05	`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	17478-546-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-546-05	`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	17478-546-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-546-05	`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	17478-546-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-546-05	`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	17478-546-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-546-05	`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	17478-546-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-546-05	`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	17478-546-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-546-05	`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	17478-546-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-546-05	`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	17478-546-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-546-05	`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	17478-546-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-546-05	`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	17478-546-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-546-05	`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	17478-546-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-546-05	`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	17478-546-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-546-05	`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	17478-546-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-546-05	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079078-001	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP		2009-09-14
A079078-002	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP		2009-09-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A079078-001	AP
A079078-002	AP

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 3 · 84 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	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079078-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079078-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2009-09-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A079078-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079078-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079078-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079078-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079078-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079078-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079078-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079078-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079078-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079078-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079078-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079078-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079078-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079078-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079078-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079078-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079078-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079078-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079078-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079078-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079078-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079078-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079078-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079078-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079078-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079078-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079078-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079078-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079078-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079078-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079078-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079078-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079078-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079078-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079078-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079078-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079078-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079078-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079078-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079078-002	AP	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfd5f35c-827b-432c-9fef-0869f8899c80	Product name	1	20260105
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
bd0ef290-bb63-6056-ab17-adf968a44900	Product name	2	20170616
d7be5b36-17f0-843a-22b1-df15cb96e594	Product name	3	20170616
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e5d20d92-e4d9-43c9-9475-8f368311d104	Product name	2	20170501
5a6fb99e-671a-4b1d-a9dc-1e7566682136	Product name	1	20160831
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
5c6cdff6-4525-6e4a-2964-09019d52be11	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
ae524849-1812-2c3b-219e-58a687215e77	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-546-02	2024-01-30	C162847	48780-1	1030e365-5250-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION, USP. GRANISETRON HYDROCHLORIDE injection USP, for intravenous use Initial U.S. Approval: 1993
17478-546-05	2024-01-30	C162847	48780-1	1030e365-5250-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION, USP. GRANISETRON HYDROCHLORIDE injection USP, for intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-546-02	Granisetron Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	15
17478-546-02	Granisetron Hydrochloride	1 in 1 CARTON	INJECTION	1	15
17478-546-05	Granisetron Hydrochloride	1 in 1 CARTON	INJECTION	1	15
17478-546-05	Granisetron Hydrochloride	4 mL in 1 VIAL, MULTI-DOSE	INJECTION	4	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-546-02	ML - Milliliter	17478-546	3426420e-885d-4652-912b-466289916f89	1	2012-07-24
17478-546-05	ML - Milliliter	17478-546	9d9ee45d-039c-4c38-bb77-96ca91c99aa6	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 INJECTION [AKORN, INC.]	8
Granisetron	ACTIVE MOIETY	WZG3J2MCOL	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Trisodium Citrate Dihydrate	INACTIVE INGREDIENT	B22547B95K	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8
Water	INACTIVE INGREDIENT	059QF0KO0R	GRANISETRON HYDROCHLORIDE INJECTION [AKORN, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-546	GRANISETRON HYDROCHLORIDE INJECTION [AKORN]	15	Legacy NDC, 4 package rows	20220914_02f350c9-b7d2-4906-af28-70ed4461ff23.zip

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
1734399	granisetron HCl 1 MG in 1 ML Injection	PSN	02f350c9-b7d2-4906-af28-70ed4461ff23	15
240912	granisetron HCl 1 MG/ML Injectable Solution	PSN	02f350c9-b7d2-4906-af28-70ed4461ff23	15
1734399	1 ML granisetron 1 MG/ML Injection	SCD	02f350c9-b7d2-4906-af28-70ed4461ff23	15
240912	granisetron 1 MG/ML Injectable Solution	SCD	02f350c9-b7d2-4906-af28-70ed4461ff23	15
1734399	granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML Injection	SY	02f350c9-b7d2-4906-af28-70ed4461ff23	15
240912	granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable Solution	SY	02f350c9-b7d2-4906-af28-70ed4461ff23	15
1734399	granisetron 1 MG per 1 ML Injection	SY	02f350c9-b7d2-4906-af28-70ed4461ff23	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-546-02	17478054602	1 VIAL, SINGLE-DOSE in 1 CARTON (17478-546-02) > 1 mL in 1 VIAL, SINGLE-DOSE	2009-10-01	0000-00-00	No	No	Current
17478-546-05	17478054605	1 VIAL, MULTI-DOSE in 1 CARTON (17478-546-05) > 4 mL in 1 VIAL, MULTI-DOSE	2009-10-01	0000-00-00	No	No	Current