Vitalipid N

Product NDC
65219-337
11-digit product format
652190337
Labeler code
65219
Product ID
65219-337_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
.ALPHA.-TOCOPHEROL, DL-; ERGOCALCIFEROL; PHYTONADIONE; VITAMIN A PALMITATE
Active strength
.7; 40; 20; 230 [iU]/mL; [iU]/mL; ug/mL; [iU]/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

Additional Listing Data#

Finished product
Yes
Brand name base
Vitalipid N
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.ALPHA.-TOCOPHEROL, DL-.7 [iU]/mL
ERGOCALCIFEROL40 [iU]/mL
PHYTONADIONE20 ug/mL
VITAMIN A PALMITATE230 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVS041H42XC, 7QWA1RIO01, A034SE7857, 1D1K0N0VVC

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
a1367f07-14a3-4895-a6e7-61ee9285308bProduct name120190415
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-337-10Vitalipid N10 mL in 1 AMPULEEMULSION102
65219-337-62Vitalipid N10 in 1 CARTONEMULSION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-337VITALIPID N (VITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE) EMULSION [FRESENIUS KABI USA, LLC]2Current NDC, 2 package rows20230916_704119cc-d2ad-408a-b213-fe232f7fe2ba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-337-106521903371010 mL in 1 AMPULE10 mlHistorical
65219-337-626521903376210 AMPULE in 1 CARTON (65219-337-62) / 10 mL in 1 AMPULE (65219-337-10) 10 ampule2023-08-18NoNoCurrent