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
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
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 |
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 | .7 [iU]/mL |
| ERGOCALCIFEROL | 40 [iU]/mL |
| .ALPHA.-TOCOPHEROL, DL- | 20 ug/mL |
| PHYTONADIONE | 230 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VS041H42XC, 1D1K0N0VVC, A034SE7857, 7QWA1RIO01 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-337-10 | Vitalipid N | 10 mL in 1 AMPULE | EMULSION | 10 | | 2 |
| 65219-337-62 | 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 |
|---|
| 65219-337 | 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-337-10 | 65219033710 | 10 mL in 1 AMPULE | 10 ml | | | | Historical |
| 65219-337-62 | 65219033762 | 10 AMPULE in 1 CARTON (65219-337-62) / 10 mL in 1 AMPULE (65219-337-10) | 10 ampule | 2023-08-18 | No | No | Current |