Palonosetron Hydrochloride

Product NDC: 0781-3312
11-digit product format: 007813312
Labeler code: 0781
Product ID: 0781-3312_efda8bac-8bb7-4e4c-b4f4-6bc540247a80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Palonosetron Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA202521
Marketing category: ANDA
Marketing start: 2018-03-23
Substance: PALONOSETRON HYDROCHLORIDE
Active strength: .25 mg/5mL
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

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
A202521-001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202521-001	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 · 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	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202521-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-13	`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	A202521-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202521-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202521-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202521-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202521-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202521-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202521-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202521-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202521-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202521-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202521-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202521-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202521-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202521-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202521-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202521-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202521-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202521-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202521-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202521-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202521-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202521-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202521-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202521-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202521-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202521-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202521-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202521-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202521-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202521-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202521-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202521-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202521-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202521-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202521-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202521-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202521-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202521-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202521-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202521-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Palonosetron Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
23310D4I19	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1728055	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
aff1505c-8d34-46e6-9559-c5b112887875	Available on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-3312-75	Palonosetron Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1	23
0781-3312-75	Palonosetron Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	23
0781-3312-95	Palonosetron Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	23
0781-3312-95	Palonosetron Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3312-75	ML - Milliliter	0781-3312	985fcd06-9a3e-4fd6-a3f6-f4414f66823c	1	2018-04-19
0781-3312-95	ML - Milliliter	0781-3312	c060514b-f018-440d-bcf2-9f9c0205e7e3	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3312	PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [SANDOZ INC]	23	Current NDC, Legacy NDC, 4 package rows	20240823_aff1505c-8d34-46e6-9559-c5b112887875.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
Palonosetron Hydrochloride	PALONOSETRON HYDROCHLORIDE	Sandoz Inc	5bfb3984-2b47-4e06-9bbb-d055ebc376c8	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202521 application number: ANDA202521
Palonosetron Hydrochloride	PALONOSETRON HYDROCHLORIDE	Sandoz Inc	aff1505c-8d34-46e6-9559-c5b112887875	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202521 application number: ANDA202521 ndc (product): 0781-3312

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	aff1505c-8d34-46e6-9559-c5b112887875	23
1728055	5 ML palonosetron 0.05 MG/ML Injection	SCD	aff1505c-8d34-46e6-9559-c5b112887875	23
1728055	palonosetron 0.25 MG per 5 ML Injection	SY	aff1505c-8d34-46e6-9559-c5b112887875	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3312-75	00781331275	1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75) / 5 mL in 1 VIAL, SINGLE-DOSE	2018-03-23	0000-00-00	No	No	Current
0781-3312-95	00781331295	10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-95) / 5 mL in 1 VIAL, SINGLE-DOSE	2024-10-01		No	No	Current