Palonosetron Hydrochloride

Product NDC: 83634-777
11-digit product format: 836340777
Labeler code: 83634
Product ID: 83634-777_2b7c65dc-88e9-4e1d-8751-43ff4878d913
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palonosetron hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Avenacy, Inc.
Application: ANDA202951
Marketing category: ANDA
Marketing start: 2024-05-15
Substance: PALONOSETRON HYDROCHLORIDE
Active strength: .05 mg/mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	83634-777		D	Discontinued by firm		2026-09-14
excluded package	package	83634-777	83634-777-05	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202951-001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29
A202951-002	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202951-002	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 · 70 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
2026-09-14 22:38:34	2026-08	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2021-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2021-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A202951-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202951-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2021-06-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202951-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202951-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202951-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202951-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202951-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202951-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202951-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202951-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202951-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202951-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202951-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202951-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202951-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202951-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202951-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202951-002	AP	1	`8072bd15b7f6…`
2021-12-28 21:50 UTC	2021-12	A202951-002	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202951-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202951-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202951-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202951-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202951-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202951-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202951-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202951-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202951-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202951-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202951-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202951-002	AP	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202951-002	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61b26fe6-497b-4f61-a1b1-af738421df7e	Product name	1	20260128
bcdb3cc7-59df-d946-62ec-4c975de6d4f2	Product name	9	20241009
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7746e9ce-fd27-4057-b741-9dd7c859eeee	Product name	1	20190219
1daa29fd-a861-43a1-a466-85dcbb6be7ec	Product name	2	20180620
06499cfd-dc01-4a13-ac2b-7239d959d760	Product name	1	20180124
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83634-777-05	Palonosetron Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5		1
83634-777-05	Palonosetron Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-777-05	ML - Milliliter	83634-777	03040b09-c5aa-46f5-b19c-2f2a8b1bc87a	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-777	PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [AVENACY, INC.]	1	Current NDC, 2 package rows	20240515_0063b66a-a71b-473c-97b8-7c59f2a5b18e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
23310D4I19	PALONOSETRON HYDROCHLORIDE	135729-62-3	PALONOSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1728055	palonosetron 0.25 MG in 5 ML Injection	PSN	0063b66a-a71b-473c-97b8-7c59f2a5b18e	1
1728055	5 ML palonosetron 0.05 MG/ML Injection	SCD	0063b66a-a71b-473c-97b8-7c59f2a5b18e	1
1728055	palonosetron 0.25 MG per 5 ML Injection	SY	0063b66a-a71b-473c-97b8-7c59f2a5b18e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83634-777-05	83634077705	1 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05) / 5 mL in 1 VIAL, SINGLE-DOSE	2024-05-15	No	No	Historical