Home NDC 69097-927 palonosetron hydrochloride
Product NDC 69097-927
11-digit product format 690970927
Labeler code 69097
Product ID 69097-927_04460041-adec-463b-ba9d-6a12038ab672
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name palonosetron hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Cipla USA Inc.
Application NDA021372
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-03-23
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 Additional Listing Data#
Finished product Yes
Brand name base palonosetron hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PALONOSETRON HYDROCHLORIDE .25 mg/5mL
Harmonized Identifiers# Field, Values table Field Values Unii 23310D4I19 Rxcui 1728055
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-927-35 palonosetron hydrochloride 5 mL in 1 VIAL INJECTION 5 4 69097-927-35 palonosetron hydrochloride 1 in 1 CARTON INJECTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-927 PALONOSETRON HYDROCHLORIDE INJECTION [CIPLA USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220114_37e7ef89-fd77-44e0-9271-ae91f8822603.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69097-927-35 69097092735 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL 1 vial 2018-03-23 0000-00-00 No No Current