Home NDC 65219-335 Vitalipid N
Product NDC 65219-335
11-digit product format 652190335
Labeler code 65219
Product ID 65219-335_804a9b58-4495-403f-9a45-8430a5f44dee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
Dosage form EMULSION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start 2023-08-18
Substance VITAMIN A PALMITATE; ERGOCALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PHYTONADIONE
Active strength 330; 20; 1; 15 [iU]/mL; [iU]/mL; [iU]/mL; ug/mL
Pharmacologic classes Ergocalciferols [CS], Increased Prothrombin Activity [PE], Provitamin D2 Compound [EPC], Reversed Anticoagulation Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vitalipid N
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VITAMIN A PALMITATE 330 [iU]/mL ERGOCALCIFEROL 20 [iU]/mL .ALPHA.-TOCOPHEROL, DL- 1 [iU]/mL PHYTONADIONE 15 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-335-10 Vitalipid N 10 mL in 1 AMPULE EMULSION 10 2 65219-335-82 Vitalipid N 10 in 1 CARTON EMULSION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-335 VITALIPID N (VITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE) EMULSION [FRESENIUS KABI USA, LLC] 2 Current NDC, 2 package rows 20230916_704119cc-d2ad-408a-b213-fe232f7fe2ba.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vitalipid N VITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE Fresenius Kabi USA, LLC 704119cc-d2ad-408a-b213-fe232f7fe2ba 2023-09-07 Exact identifier ndc (product): 65219-335
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-335-10 65219033510 10 mL in 1 AMPULE 10 ml Historical 65219-335-82 65219033582 10 AMPULE in 1 CARTON (65219-335-82) / 10 mL in 1 AMPULE (65219-335-10) 10 ampule 2023-08-18 No No Current