FDA.reportPublic FDA data

Palonosetron Hydrochloride

Product NDC
0703-4094
11-digit product format
007034094
Labeler code
0703
Product ID
0703-4094_124fd0ad-cda6-4a00-9355-c4809c039c74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA090713
Marketing category
ANDA
Marketing start
2018-03-23
Marketing end
2026-12-31
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
.25 mg/5mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Palonosetron Hydrochloride

Active Ingredients#

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

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
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0703-4094-01Palonosetron Hydrochloride5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION59
0703-4094-01Palonosetron Hydrochloride1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-4094-01ML - Milliliter0703-4094c007141a-5e95-420b-930b-8d8f79a2f8a412018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-4094PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]7Current NDC, Legacy NDC, 2 package rows20200723_911783eb-91a8-4ef4-bd6f-809211e207d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728055palonosetron 0.25 MG in 5 ML InjectionPSN911783eb-91a8-4ef4-bd6f-809211e207d69
17280555 ML palonosetron 0.05 MG/ML InjectionSCD911783eb-91a8-4ef4-bd6f-809211e207d69
1728055palonosetron 0.25 MG per 5 ML InjectionSY911783eb-91a8-4ef4-bd6f-809211e207d69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-4094-01007034094011 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) / 5 mL in 1 VIAL, SINGLE-USE2018-03-232026-12-31NoNoCurrent