posfrea

Product NDC: 83831-105
11-digit product format: 838310105
Labeler code: 83831
Product ID: 83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palonosetron
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Avyxa Pharma, LLC
Application: NDA203050
Marketing category: NDA
Marketing start: 2024-09-30
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203050-001	POSFREA	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2016-03-01
N203050-002	POSFREA	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-03-01

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203050-001	POSFREA	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203050-002	POSFREA	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203050-001	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203050-002	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		2016-03-01	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: posfrea
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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1728050	Internal RxNorm lookup
1728055	Internal RxNorm lookup
2688837	Internal RxNorm lookup
2688839	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
13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
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
83831-105-01	posfrea	1 in 1 CARTON	INJECTION, SOLUTION	1		7
83831-105-01	posfrea	5 mL in 1 VIAL, SINGLE-DOSE	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
83831-105-01	ML - Milliliter	83831-105	ed6bb053-27cb-4596-b4d9-182b68b57cca	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83831-105	POSFREA (PALONOSETRON) INJECTION, SOLUTION [AVYXA PHARMA, LLC]	7	Current NDC, 2 package rows	20250430_13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7.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
posfrea	PALONOSETRON	Avyxa Pharma, LLC	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203050 application number: NDA203050 ndc (product): 83831-105

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
1728050	palonosetron 0.075 MG in 1.5 ML Injection	PSN	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
1728055	palonosetron 0.25 MG in 5 ML Injection	PSN	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
2688837	Posfrea 0.075 MG in 1.5 ML Injection	PSN	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
2688839	Posfrea 0.25 MG in 5 ML Injection	PSN	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
2688837	1.5 ML palonosetron 0.05 MG/ML Injection [Posfrea]	SBD	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
2688839	5 ML palonosetron 0.05 MG/ML Injection [Posfrea]	SBD	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
1728050	1.5 ML palonosetron 0.05 MG/ML Injection	SCD	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
1728055	5 ML palonosetron 0.05 MG/ML Injection	SCD	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
1728050	palonosetron 0.075 MG per 1.5 ML Injection	SY	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
1728055	palonosetron 0.25 MG per 5 ML Injection	SY	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
2688837	Posfrea 0.075 MG per 1.5 ML Injection	SY	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7
2688839	Posfrea 0.25 MG per 5 ML Injection	SY	13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83831-105-01	83831010501	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2024-09-30	No	No	Current