FDA.reportPublic FDA data

Palonosetron Hydrochloride

Product NDC
83634-777
11-digit product format
836340777
Labeler code
83634
Product ID
83634-777_2b7c65dc-88e9-4e1d-8751-43ff4878d913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palonosetron hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy, Inc.
Application
ANDA202951
Marketing category
ANDA
Marketing start
2024-05-15
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii23310D4I19
Rxcui1728055

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61b26fe6-497b-4f61-a1b1-af738421df7eProduct name120260128
bcdb3cc7-59df-d946-62ec-4c975de6d4f2Product name920241009
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-777-05Palonosetron Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51
83634-777-05Palonosetron Hydrochloride1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-777PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [AVENACY, INC.]1Current NDC, 2 package rows20240515_0063b66a-a71b-473c-97b8-7c59f2a5b18e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728055palonosetron 0.25 MG in 5 ML InjectionPSN0063b66a-a71b-473c-97b8-7c59f2a5b18e1
17280555 ML palonosetron 0.05 MG/ML InjectionSCD0063b66a-a71b-473c-97b8-7c59f2a5b18e1
1728055palonosetron 0.25 MG per 5 ML InjectionSY0063b66a-a71b-473c-97b8-7c59f2a5b18e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83634-777-05836340777051 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05) / 5 mL in 1 VIAL, SINGLE-DOSE2024-05-15NoNoCurrent