Palonosetron

Product NDC
67184-0514
11-digit product format
671840514
Labeler code
67184
Product ID
67184-0514_abeff9bd-6829-445c-93b8-3d9217993b9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA205648
Marketing category
ANDA
Marketing start
2018-09-19
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205648-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19
A205648-002PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205648-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205648-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205648-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205648-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205648-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205648-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205648-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205648-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205648-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205648-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205648-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205648-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205648-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205648-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205648-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205648-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205648-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205648-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205648-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205648-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205648-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205648-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205648-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205648-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205648-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A205648-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205648-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205648-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205648-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205648-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A205648-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205648-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A205648-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A205648-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205648-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205648-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205648-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205648-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205648-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205648-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205648-001AP1a72a2bbeb626…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23310D4I19Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1728050Internal RxNorm lookup
1728055Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
633abdc2-a942-4eb2-a0f8-f9f4e727211eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61b26fe6-497b-4f61-a1b1-af738421df7eProduct name120260128
bcdb3cc7-59df-d946-62ec-4c975de6d4f2Product name920241009
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0514-1Palonosetron1 in 1 CARTONINJECTION13
67184-0514-1Palonosetron5 mL in 1 VIALINJECTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0514PALONOSETRON (PALONOSETRON HYDROCHLORIDE) INJECTION [QILU PHARMACEUTICAL CO., LTD.]3Current NDC, Legacy NDC, 2 package rows20211020_633abdc2-a942-4eb2-a0f8-f9f4e727211e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRON HYDROCHLORIDEBLuePoint Laboratoriesbb2be46a-56f7-48b6-bb05-3c6b12c8b1ea2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.4af600d1-0ab1-41c5-af2f-9dc24cf3c90e2025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.903d7aba-277e-6d28-4fee-fd2d605ab6a92025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
PalonosetronPALONOSETRON HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.633abdc2-a942-4eb2-a0f8-f9f4e727211e2021-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
ndc (product): 67184-0514

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728050palonosetron 0.075 MG in 1.5 ML InjectionPSN633abdc2-a942-4eb2-a0f8-f9f4e727211e3
1728055palonosetron 0.25 MG in 5 ML InjectionPSN633abdc2-a942-4eb2-a0f8-f9f4e727211e3
17280501.5 ML palonosetron 0.05 MG/ML InjectionSCD633abdc2-a942-4eb2-a0f8-f9f4e727211e3
17280555 ML palonosetron 0.05 MG/ML InjectionSCD633abdc2-a942-4eb2-a0f8-f9f4e727211e3
1728050palonosetron 0.075 MG per 1.5 ML InjectionSY633abdc2-a942-4eb2-a0f8-f9f4e727211e3
1728055palonosetron 0.25 MG per 5 ML InjectionSY633abdc2-a942-4eb2-a0f8-f9f4e727211e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67184-0514-1671840514011 VIAL in 1 CARTON (67184-0514-1) / 5 mL in 1 VIAL1 vial2018-09-190000-00-00NoNoCurrent