Palonosetron

Product NDC
16714-834
11-digit product format
167140834
Labeler code
16714
Product ID
16714-834_8d32d892-2cbb-f22e-0084-b405875974af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA201533
Marketing category
ANDA
Marketing start
2018-05-29
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201533-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21
A201533-002PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201533-002AP

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 06:07:402026-07A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2016-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A201533-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201533-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201533-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201533-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201533-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201533-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201533-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201533-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201533-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201533-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201533-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201533-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201533-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201533-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201533-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201533-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201533-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201533-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201533-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201533-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201533-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201533-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A201533-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201533-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201533-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201533-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A201533-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201533-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201533-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201533-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201533-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201533-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201533-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201533-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201533-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201533-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201533-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201533-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201533-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201533-002AP1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
689c953c-2120-2546-67a4-22bb34ba3330Available 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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-834-01Palonosetron1 in 1 CARTONINJECTION, SOLUTION19
16714-834-01Palonosetron5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-834-01ML - Milliliter16714-8343a6b4b05-0fbb-44d8-851c-a6ab5a4923d312018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-834PALONOSETRON INJECTION, SOLUTION [NORTHSTAR RX LLC]8Current NDC, Legacy NDC, 2 package rows20241220_689c953c-2120-2546-67a4-22bb34ba3330.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRONNorthStar Rx LLC689c953c-2120-2546-67a4-22bb34ba33302025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201533
application number: ANDA201533
ndc (product): 16714-834
PalonosetronPALONOSETRONDr.Reddy's Laboratories Limited991b8452-852c-c55c-7b1b-e97c4964777a2020-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201533
application number: ANDA201533

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728055palonosetron 0.25 MG in 5 ML InjectionPSN689c953c-2120-2546-67a4-22bb34ba33309
17280555 ML palonosetron 0.05 MG/ML InjectionSCD689c953c-2120-2546-67a4-22bb34ba33309
1728055palonosetron 0.25 MG per 5 ML InjectionSY689c953c-2120-2546-67a4-22bb34ba33309

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-834-01167140834011 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE2018-05-290000-00-00NoNoCurrent