Home NDC 63323-024-01 NDC 63323-024-01 - Mannitol This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 63323-024
Requested NDC 63323-024-01
Package NDCs from labels 63323-024-01, 63323-024-25
Manufacturer ProPharma Distribution
Effective date 2025-11-07
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-024-01 Mannitol 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 4 63323-024-25 Mannitol 25 in 1 TRAY INJECTION, SOLUTION 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-024 MANNITOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20230323_c395e13d-6ea1-4104-8b37-669cfb982f04.zip
DailyMed Socrata Ingredients# 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 ยท 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mannitol MANNITOL Hospira, Inc. 8ad3145e-00e7-4412-b9a5-06f00f264f30 2026-04-21 Warnings, Adverse reactions Exact identifier rxcui: 311450 unii: 3OWL53L36A QR PAIN ANALGESIC MARYHELENE ENTERPRISES INC 8f8f53e3-fe31-e7b5-e053-2995a90a710d 2025-11-14 Warnings Exact identifier unii: 3OWL53L36A QR PAIN ANALGESIC MARYHELENE ENTERPRISES INC 9984a510-30be-4013-e053-2995a90a841e 2025-11-14 Warnings Exact identifier unii: 3OWL53L36A Mannitol MANNITOL ProPharma Distribution 430669d7-9ad1-9a04-e063-6394a90ababb 2025-11-07 Warnings, Adverse reactions Exact identifier application number: ANDA080677 ndc (package): 84549-024-25 ndc (product): 84549-024 rxcui: 311450 spl id: 430669d7-9ad0-9a04-e063-6394a90ababb spl set id: 430669d7-9ad1-9a04-e063-6394a90ababb unii: 3OWL53L36A Sorbitol-Mannitol SORBITOL AND MANNITOL ICU Medical Inc. 5b44e248-4b7b-4777-954a-921c7b309944 2025-10-30 Warnings, Adverse reactions Exact identifier unii: 3OWL53L36A Mannitol MANNITOL ICU Medical Inc. ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 2025-10-24 Warnings, Adverse reactions Exact identifier unii: 3OWL53L36A Osmitrol MANNITOL Baxter Healthcare Company 0d914965-7001-45cb-ba51-d7c5964b05bc 2025-08-26 Warnings, Adverse reactions Exact identifier unii: 3OWL53L36A Mannitol MANNITOL Henry Schein, Inc. e2444db1-9dfe-451f-a33c-9b00786464d2 2025-05-20 Warnings, Adverse reactions Exact identifier rxcui: 311450 unii: 3OWL53L36A MANNITOL MANNITOL HF Acquisition Co LLC, DBA HealthFirst 999ce711-2d5b-0d7d-e053-2995a90a2689 2024-01-27 Warnings, Adverse reactions Exact identifier rxcui: 311450 unii: 3OWL53L36A Mannitol MANNITOL B. Braun Medical Inc. d12cc802-b538-4065-a264-f474ff3b3043 2023-08-15 Warnings, Adverse reactions Exact identifier unii: 3OWL53L36A Mannitol MANNITOL Fresenius Kabi USA, LLC c395e13d-6ea1-4104-8b37-669cfb982f04 2023-03-16 Warnings, Adverse reactions Exact identifier application number: ANDA080677 ndc (package): 63323-024-25 ndc (package): 63323-024-01 ndc (product): 63323-024 ndc11 (package): 63323002401 rxcui: 311450 spl id: fe8beed4-a8db-400e-834e-b5efe2f5af1c spl set id: c395e13d-6ea1-4104-8b37-669cfb982f04 unii: 3OWL53L36A
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.