GRANISETRON HYDROCHLORIDE

Product NDC: 55648-661
11-digit product format: 556480661
Labeler code: 55648
Product ID: 55648-661_dae3e3e8-5de8-412f-9b98-6443c9d2edc0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GRANISETRON HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: WOCKHARDT LIMITED
Application: ANDA078564
Marketing category: ANDA
Marketing start: 2008-06-30
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: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-661		I	Inactivated by FDA	2026-08-17
excluded product	product	55648-661		I	Inactivated by FDA	2026-08-17
excluded package	package	55648-661	55648-661-01	I	Inactivated by FDA	2026-08-17
excluded package	package	55648-661	55648-661-02	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 · 88 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	55648-661-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-661-01	`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	55648-661-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-661-01	`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	55648-661-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-661-01	`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	55648-661-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-661-01	`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	55648-661-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-661-01	`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	55648-661-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-661-01	`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	55648-661-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-661-01	`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	55648-661-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-661-01	`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	55648-661-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-661-01	`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	55648-661-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-661-01	`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	55648-661-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-661-01	`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	55648-661-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-661-01	`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 product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-661-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-661-01	`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 product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-661-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-661-01	`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 product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-661-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-661-01	`1332a3947898…`	`d4bfe170f9cd…`

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
A078564-001	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION			2008-06-30

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	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2008-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078564-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION		2008-06-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078564-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078564-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078564-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078564-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078564-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078564-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078564-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078564-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078564-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078564-001	AP	1	`ea99ee380514…`

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
55648-661-01	2020-01-31	C162847	48780-1	9d75b9d0-8524-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993
55648-661-02	2020-01-31	C162847	48780-1	9d75b9d1-0879-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. 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
55648-661-02	GRANISETRON HYDROCHLORIDE	4 mL in 1 VIAL, MULTI-DOSE	INJECTION	4	2
55648-661-02	GRANISETRON HYDROCHLORIDE	1 in 1 CARTON	INJECTION	1	2
55648-661-01	GRANISETRON HYDROCHLORIDE	5 in 1 CARTON	INJECTION	5	1
55648-661-03	GRANISETRON HYDROCHLORIDE	1 in 1 CARTON	INJECTION	1	1
55648-661-03	GRANISETRON HYDROCHLORIDE	1 mL in 1 VIAL, SINGLE-USE	INJECTION	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GRANISETRON HYDROCHLORIDE	ACTIVE INGREDIENT	318F6L70J8	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
GRANISETRON	ACTIVE MOIETY	WZG3J2MCOL	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2
GRANISETRON HYDROCHLORIDE	ACTIVE INGREDIENT	318F6L70J8	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
GRANISETRON	ACTIVE MOIETY	WZG3J2MCOL	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-661	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	2	Legacy NDC, 2 package rows	20120203_af68579f-c863-4535-94af-a4126b43c182.zip
55648-661	GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1	Legacy NDC, 3 package rows	20120215_fb723c47-002e-4243-9c5e-448f5cfd6d68.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
240912	granisetron HCl 1 MG/ML Injectable Solution	PSN	af68579f-c863-4535-94af-a4126b43c182	2
240912	granisetron 1 MG/ML Injectable Solution	SCD	af68579f-c863-4535-94af-a4126b43c182	2
240912	granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable Solution	SY	af68579f-c863-4535-94af-a4126b43c182	2
240912	granisetron HCl 1 MG/ML Injectable Solution	PSN	fb723c47-002e-4243-9c5e-448f5cfd6d68	1
240912	granisetron 1 MG/ML Injectable Solution	SCD	fb723c47-002e-4243-9c5e-448f5cfd6d68	1
240912	granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable Solution	SY	fb723c47-002e-4243-9c5e-448f5cfd6d68	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55648-661-01	55648066101	5 in 1 CARTON		Historical
55648-661-02	55648066102	4 mL in 1 VIAL, MULTI-DOSE	4 ml	Historical
55648-661-03	55648066103	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GRANISETRON HYDROCHLORIDE	WOCKHARDT LIMITED	2011-12-20	HUMAN PRESCRIPTION DRUG LABEL	2
GRANISETRON HYDROCHLORIDE	WOCKHARDT LIMITED	2011-12-07	HUMAN PRESCRIPTION DRUG LABEL	1