Palonosetron

Product NDC: 68001-355
11-digit product format: 680010355
Labeler code: 68001
Product ID: 68001-355_2cefd5b7-b32d-7b91-e063-6394a90af3b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Palonosetron
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA201533
Marketing category: ANDA
Marketing start: 2018-05-30
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

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
A201533-001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21
A201533-002	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201533-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2016-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201533-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2016-04-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201533-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2016-04-21	`bb7c543d1eb4…`

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	A201533-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201533-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201533-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201533-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201533-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201533-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201533-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201533-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201533-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201533-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201533-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201533-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201533-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201533-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201533-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201533-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201533-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201533-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201533-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201533-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201533-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201533-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201533-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201533-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201533-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201533-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201533-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201533-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201533-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201533-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201533-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201533-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201533-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201533-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201533-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201533-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201533-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201533-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201533-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201533-002	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.05 mg/mL

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-355-25	Palonosetron	1 in 1 CARTON	INJECTION, SOLUTION	1		7
68001-355-25	Palonosetron	5 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	5		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-355-25	ML - Milliliter	68001-355	7a9a9019-1859-41a4-b955-bedb3ca08d1e	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-355	PALONOSETRON INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	7	Current NDC, Legacy NDC, 2 package rows	20250131_ee6f6f94-1ca7-481e-9909-b19ae64e80c2.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	PALONOSETRON	NorthStar Rx LLC	689c953c-2120-2546-67a4-22bb34ba3330	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201533 application number: ANDA201533
Palonosetron	PALONOSETRON	Dr.Reddy's Laboratories Limited	991b8452-852c-c55c-7b1b-e97c4964777a	2020-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201533 application number: ANDA201533

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
23310D4I19	PALONOSETRON HYDROCHLORIDE	135729-62-3	PALONOSETRON HYDROCHLORIDE
5D06587D6R	PALONOSETRON	135729-61-2	Palonosetron

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	ee6f6f94-1ca7-481e-9909-b19ae64e80c2	7
1728055	5 ML palonosetron 0.05 MG/ML Injection	SCD	ee6f6f94-1ca7-481e-9909-b19ae64e80c2	7
1728055	palonosetron 0.25 MG per 5 ML Injection	SY	ee6f6f94-1ca7-481e-9909-b19ae64e80c2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-355-25	68001035525	1 VIAL, SINGLE-USE in 1 CARTON (68001-355-25) / 5 mL in 1 VIAL, SINGLE-USE	2018-05-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Palonosetron	BluePoint Laboratories \| Dr.Reddy's Laboratories Limited \| Gland Pharma Limited	2026-08-25	HUMAN PRESCRIPTION DRUG LABEL	8