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Vitalipid N VITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE 330 [iU]/mL; 20 [iU]/mL; 1 [iU]/mL; 15 ug/mL Emulsion — NDC 65219-335-82 (Billing 65219-0335-82)

by Fresenius Kabi USA, LLC · 10 AMPULE in 1 CARTON / 10 mL in 1 AMPULE

This is a package of Vitalipid N VITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE 330 [iU]/mL; 20 [iU]/mL; 1 [iU]/mL; 15 ug/mL Emulsion from Fresenius Kabi USA, LLC, marketed since Aug 2023 and currently FDA-listed. It is this product's only package size.

NDC 65219-0335-82
🏷️ FDA NDC (as labeled) 65219-335-82 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 65219-335-82 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65219 labeler · 335 product · 82 package
Package marketed since
Aug 18, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6521933582 5
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-335-82
Product NDC 65219-335
11-digit billing NDC 65219033582
NCPDP billing unit ML — per mL (volume)
UNII VS041H42XC, A034SE7857, 1D1K0N0VVC, 7QWA1RIO01
SPL Set ID 704119cc-d2ad-408a-b213-fe232f7fe2ba
Established class (EPC) Provitamin D2 Compound; Vitamin K; Warfarin Reversal Agent
Physiologic effect Increased Prothrombin Activity; Reversed Anticoagulation Activity
Chemical class Ergocalciferols; Vitamin K
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-18
Route INTRAVENOUS
Dosage form EMULSION
Substance VITAMIN A PALMITATE; ERGOCALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PHYTONADIONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 063895
GCN 99607
HICL code 013336
Ingredient (HICL) Fat Emuls/Vit A/Vit D2/E/Vit K
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6Z
Therapeutic class — specific (HIC3) Multivitamin Preparations
AHFS code 88:28.00.00
AHFS class Multivitamin Preparations
FDB label name VITLIPID N ADULT AMPULE
FDB brand name Vitlipid N Adult
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063895
  • GCN: 99607
  • HICL (First Databank): 013336
  • AHFS class code: 88:28.00.00
Why two NDCs? The FDA registers this code as 65219-335-82 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65219-0335-82. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name VITLIPID N ADULT AMPULE Ingredient Fat Emuls/Vit A/Vit D2/E/Vit K
🧪 What is this product?

Vitalipid N is an intravenous emulsion containing four fat-soluble vitamins: vitamin A palmitate, ergocalciferol (vitamin D2), alpha-tocopherol (vitamin E), and phytonadione (vitamin K). These vitamins are typically used to prevent or treat deficiencies in patients who cannot take vitamins by mouth and require intravenous nutrition support. This product is marketed without an approved FDA application and is available for use during drug shortages.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65219-0335-82 You're viewing this Main listing 10 AMPULE in 1 CARTON / 10 mL in 1 AMPULE 2023-08-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vitalipid N 330 [iU]/mL; 20 [iU]/mL; 1 [iU]/mL; 15 ug/mLthis 65219-0335-82 Fresenius 10 ampules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Labeler code65219
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 65219

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID ® N Infant 10 mL Ampule Label Vitalipid ® N Infant 10 ml Concentrate for emulsion for infusion For intravenous infusion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID® N Infant 10 mL Ampule Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID ® N Infant 10 mL Ampule Carton Panel Vitalipid ® N Infant Concentrate for emulsion for infusion For intravenous infusion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID™ N Infant 10 mL Ampule Label Vitalipid ™ N Infant 10 ml Concentrate for solution for infusion, emulsion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID™ N Infant 10 mL Ampule Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID™ N Infant 10 mL Ampule Carton Panel Vitalipid ™ N Infant Concentrate for solution for infusion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID™ N Infant 10 mL Ampule Carton Panel

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID ® N Adult 10 mL Ampule Label Vitalipid ® N Adult 10 ml Concentrate for emulsion for infusion For intravenous infusion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID ® N Adult 10 mL Ampule Carton Panel Vitalipid ® N Adult Concentrate for emulsion for infusion For intravenous infusion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VITALIPID

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug For Use In Drug Shortage". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65219-0328-50 · Fresenius 65219-0337-62 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.