Granisetron Hydrochloride

Product NDC: 67457-864
11-digit product format: 674570864
Labeler code: 67457
Product ID: 67457-864_9baf50f5-8a78-4532-af34-57f5d0c74dae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Granisetron Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA091137
Marketing category: ANDA
Marketing start: 2018-03-21
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: 2027-12-31
Current FDA listing: Yes

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
A091137-002	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP		2010-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091137-002	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091137-002	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`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	A091137-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091137-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091137-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091137-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091137-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091137-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091137-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091137-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091137-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091137-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091137-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091137-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091137-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091137-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091137-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091137-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091137-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091137-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091137-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091137-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091137-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091137-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091137-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091137-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091137-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091137-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091137-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091137-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091137-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091137-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091137-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091137-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091137-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091137-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091137-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091137-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091137-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091137-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091137-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091137-002	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Granisetron Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GRANISETRON HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
318F6L70J8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240912	Internal RxNorm lookup
543218	Internal RxNorm lookup
1734399	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d88adba-7f5e-4e97-84b3-6ca8ec98c023	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-864-04	Granisetron Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		4
67457-864-04	Granisetron Hydrochloride	1 mL in 1 VIAL	INJECTION, SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-864-04	ML - Milliliter	67457-864	4a8a0c0d-b027-4755-8de0-08107dab40b9	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-864	GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	3	Current NDC, Legacy NDC, 2 package rows	20230111_8d88adba-7f5e-4e97-84b3-6ca8ec98c023.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Mylan Institutional LLC	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	2017-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091137 application number: ANDA091137 ndc (product): 67457-864

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
543218	granisetron HCl 0.1 MG in 1 ML Injection	PSN	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
1734399	granisetron HCl 1 MG in 1 ML Injection	PSN	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
240912	granisetron HCl 1 MG/ML Injectable Solution	PSN	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
543218	1 ML granisetron 0.1 MG/ML Injection	SCD	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
1734399	1 ML granisetron 1 MG/ML Injection	SCD	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
240912	granisetron 1 MG/ML Injectable Solution	SCD	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
543218	granisetron 0.1 MG per 1 ML Injection	SY	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
543218	granisetron 0.1 MG/ML (as granisetron HCl 0.112 MG/ML) Injection	SY	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
1734399	granisetron 1 MG (as granisetron HCl 1.12 MG) per 1 ML Injection	SY	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
240912	granisetron 1 MG (as granisetron HCl 1.12 MG) per ML Injectable Solution	SY	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4
1734399	granisetron 1 MG per 1 ML Injection	SY	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-864-04	67457086404	1 VIAL in 1 CARTON (67457-864-04) / 1 mL in 1 VIAL	1 vial	2018-03-21	0000-00-00	No	No	Current