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Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Kit — NDC 54643-9031-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Kit — NDC 54643-9031-0 (Billing 54643-9031-00)

by Sandoz Inc · 1 KIT in 1 CARTON * 40 mL in 1 VIAL * 10 mL in 1 VIAL

This is a package of Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Kit from Sandoz Inc, marketed since Dec 2016 and currently FDA-listed, this package's marketing is listed to end Oct 2026. It is this product's only package size.

NDC 54643-9031-00
🏷️ FDA NDC (as labeled) 54643-9031-0 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54643-9031-0
Product NDC 54643-9031
11-digit billing NDC 54643903100
NCPDP billing unit ML — per mL (volume)
RxCUI 1305217, 1305222
UNII PQ6CK8PD0R, 1D1K0N0VVC, 1C6V77QF41, M572600E5P, 20RD1DZH99, 68Y4CF58BV +7 more
Application # NDA021646
SPL Set ID 4ff223f7-e076-4e81-8151-5c06724fabd9
Established class (EPC) Vitamin C; Vitamin D; Vitamin K; Warfarin Reversal Agent; Vitamin B12
Physiologic effect Increased Prothrombin Activity; Reversed Anticoagulation Activity
Chemical class Ascorbic Acid; Vitamin D; Vitamin K; Vitamin B 12
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-12-23
Marketing end 2026-10-31
Dosage form KIT

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

GPI-14 78410000002050
GPI class Infuvite Pediatric
GCN Seq No 058198
GCN 23555
HICL code 026696
Ingredient (HICL) Multivit Infusion,Pedi 1,Vit K
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6H
Therapeutic class — specific (HIC3) Pediatric Vitamin Preparations
AHFS code 88:28.00.00
AHFS class Multivitamin Preparations
FDB label name INFUVITE PEDIATRIC BULK VIAL
FDB brand name Infuvite Pediatric
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058198
  • GCN: 23555
  • GPI-14 (Medi-Span): 78410000002050
  • HICL (First Databank): 026696
  • AHFS class code: 88:28.00.00
  • RxCUI (RxNorm): 1305217
Why two NDCs? The FDA registers this code as 54643-9031-0 — a 5-4-1 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 package segment → 54643-9031-00. 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.

RxNorm drug class

This medicine belongs to the Vitamin B1, plain class.

Drug family (ATC) Vitamin B1, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name INFUVITE PEDIATRIC BULK VIAL Ingredient Multivit Infusion,Pedi 1,Vit K

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 eachPer 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
54643-9031-00 You're viewing this Main listing 1 KIT in 1 CARTON * 40 mL in 1 VIAL * 10 mL in 1 VIAL 2016-12-23 Oct 31, 2026 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Infuvite Pediatric 54643-5646-00 Sandoz 2 vials — AP FDA listed —
Infuvite Pediatric 54643-5647-00 Sandoz 1 kit — AP FDA listed —
Pediatric Infuvite Multiple Vitamins 80 mg/5mL; 2300 [iU]/5mL; 400 [iU]/5mL; 1.2 mg/5mL; 5'-PHOSPHATE SODIUM 1.4 mg/5mL; 1 mg/5mL; 17 mg/5mL; 5 mg/5mL 54643-9023-01 Sandoz 10 vials — AP FDA listed —
Pediatric Infuvite Multiple Vitaminsthis 54643-9031-00 Sandoz 1 kit — — FDA listed —
Multiple Vitamins (Pediatric) Single Dose Vial 60505-6190-00 Apotex 1 kit — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2016
On the market since
Dec 2016
📍
2026
Currently FDA-listed
10 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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

LabelerSandoz Inc
FDA applicationNDA021646 (NDA)
Labeler code54643
First marketedDec 2016
Product typeHuman Prescription Drug
Portfolio391 products on file
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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 ( 2.1 ) • INFUVITE PEDIATRIC is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is based on patient’s actual weight ( 2.2 ): • INFUVITE PEDIATRIC Single Dose: o Weight less than 1 kg: 1.2 mL of Vial 1 and 0.3 mL of Vial 2 o Weight 1 kg to less than 3 kg: 2.6 mL of Vial 1 and 0.65 mL Vial 2 o Weight 3 kg or greater: 4 mL of Vial 1 and 1 mL of Vial 2 • INFUVITE PEDIATRIC Pharmacy Bulk Package : o Weight less than 1 kg: 1.5 mL of combined content of Vials 1 and 2 o Weight 1 kg to less than 3 kg: 3.25 mL of combined content of Vials 1 and 2 o Weight 3 kg or greater: 5 mL of combined content of Vials 1 and 2. • Supplemental vitamin A may be required for low-birth weight infants ( 2.2 ) • INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk package: • Single Dose consists of two vials labeled Vial 1 and Vial 2.

Add one daily dose of Vial 1 and one daily dose of Vial 2 directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 ) • Pharmacy Bulk Package consists of two vials labeled Vial 1 and Vial 2. Transfer contents of Vial 2 to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or 5 mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 ) • After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately.

Use solution within 24 hours after dilution ( 2.3 ) • Monitor blood vitamin concentrations ( 2.4 ) • See Full Prescribing Information for drug incompatibilities ( 2.5 ).

2.1Important Dosage Instructions INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 . INFUVITE PEDIATRIC is supplied as a single dose or as a pharmacy bulk package, for intravenous use intended for administration by intravenous infusion after dilution: • INFUVITE PEDIATRIC Single Dose consists of two vials. A weight-based volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [ see Dosage and Administration ( 2.2 , 2.3 ) ]. • INFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use.

The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. [ see Dosage and Administration ( 2.2 , 2.3 ) ].

2.2Dosage Information The recommended daily dosage volume is based on the patient's actual weight less than 1 kg, 1 kg to less than 3 kg, and 3 kg or greater. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. Supplemental vitamin A may be required for low-birth weight infants.

Additional daily dosages of Vitamin E in infants are not recommended [see Warnings and Precautions ( 5.8 )]. INFUVITE PEDIATRIC Single Dose (see Table 1): One daily dose of Vial 1 (1.2 mL, 2.6 mL or 4 mL) and one daily dose of Vial 2 (0.3 mL, 0.65 mL or 1 mL) based on the patient’s weight are added directly to a specified volume of an intravenous fluid [ see Dosage and Administration ( 2.3 ) ] (see Table 1). Table 1: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Single Dose Less than 1 kg 1 kg to less than 3 kg 3 kg or greater Daily Dosage Volume – Vial 1 1.2 mL 2.6 mL 4 mL… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 175 words ▾

3 DOSAGE FORMS AND STRENGTHS INFUVITE PEDIATRIC Single Dose is an injection consisting of two single-dose vials labeled Vial 1 (4 mL) and Vial 2 (1 mL). For the vitamin strengths [ see Dosage and Administration ( 2.2 ) and Description ( 11 ) ]. INFUVITE PEDIATRIC Pharmacy Bulk Package is an injection consisting of two vials labeled Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL).

The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses. For the vitamin strengths [ see Dosage and Administration ( 2.2 ) and Description ( 11 ) ]. • INFUVITE PEDIATRIC single dose is an injection consisting of two vials labeled Vial 1 (4 mL) and Vial 2 (1 mL) ( 3 ) • INFUVITE PEDIATRIC pharmacy bulk package is an injection consisting of two vials labeled Vial 1 (50 mL) and Vial 2 (10 mL) ( 3 ) • See Full Prescribing Information for vitamin strengths ( 11 )

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS INFUVITE PEDIATRIC is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions: To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 ) • Risk of Vitamin E Toxicity: Additional oral and parenteral vitamin E may result in elevated vitamin E blood concentrations in infants ( 5.8 ) • Low Vitamin A Levels: Monitor vitamin A levels ( 5.9 ) • Risk of E-Ferol Syndrome: Due to polysorbates ( 5.10 )

5.1Aluminum Toxicity INFUVITE PEDIATRIC contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in pediatric patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of INFUVITE PEDIATRIC.

5.2Allergic Reactions to Thiamine Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in INFUVITE PEDIATRIC. There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis associated with INFUVITE PEDIATRIC has been reported.

5.3. Hypervitaminosis A Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in INFUVITE PEDIATRIC, should be undertaken with caution [ see Use in Specific Populations ( 8.6 , 8.7 ) ].

Blood levels of Vitamin A should be monitored periodically.

5.4Decreased Anticoagulant Effect of Warfarin INFUVITE PEDIATRIC contains Vitamin K which may decrease the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving INFUVITE PEDIATRIC monitor blood levels of prothrombin/INR to determine if dose of warfarin needs to be adjusted.

5.5Interference with Diagnosis of Megaloblastic Anemia INFUVITE PEDIATRIC contains folic acid and cyanocobalamin which can mask serum deficiencies of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of INFUVITE PEDIATRICS in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.

5.6Potential to Develop Vitamin Deficiencies or Excesses In patients receiving parenteral multivitamins such as with INFUVITE PEDIATRIC, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. INFUVITE PEDIATRIC may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may be required [ see Dosage and Administration ( 2.2 ) ].

5.7Interference with Urine Glucose Testing INFUVITE PEDIATRIC contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 130 words ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of INFUVITE PEDIATRIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions. Effect of INFUVITE PEDIATRIC on other drugs : • Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin ( 7.1 ) • Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin ( 7.1 ) • Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease ( 7.1 ) • Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity ( 7.1 ) • Methotrexate: Folic acid may decrease response to methotrexate ( 7.1 ) Effects of other drugs on INFUVITE PEDIATRIC: • Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ). • Phenytoin: May decrease folic acid concentrations ( 7.2 )

7.1Drug Interactions Affecting Co-administered Drugs Warfarin : Vitamin K, a component of INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVITE PEDIATRIC, blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [ see Warnings and Precautions ( 5.4 ) ]. Antibiotics : Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.

Bleomycin : Ascorbic acid and riboflavin inactivate bleomycin in vitro , thus the activity of bleomycin may be reduced. Levodopa : Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy. Phenytoin : Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity.

Methotrexate : Folic acid may decrease a patient’s response to methotrexate therapy.

7.2Drug Interactions Affecting Vitamin Levels Hydralazine, Isoniazid : Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin : Phenytoin may decrease serum folic acid concentrations.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS • Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin A levels ( 8.6 ) • Hepatic Impairment: Monitor vitamin A levels ( 8.7 )

8.1Pregnancy Pregnancy Category C. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection).

8.3Nursing Mothers INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers.

8.4Pediatric Use INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years. INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates.

Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [ see Warnings and Precautions ( 5.1 ) ]. Additional vitamin E supplementations of infants receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity [ see Warnings and Precautions ( 5.8 ) ]. E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates which are found in INFUVITE PEDIATRIC.

No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported [ see Warnings and Precautions ( 5.10 ) ].

8.6Renal Impairment INFUVITE PEDIATRIC has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [ see Warnings and Precautions ( 5.1 , 5.3 ) ] .

8.7Hepatic Impairment INFUVITE PEDIATRIC has not been studied in patients with liver impairment. Monitor vitamin A levels in patients with liver disease [ see Warnings and Precautions ( 5.3 ) ] .

🤰 Pregnancy 48 words ▾

8.1Pregnancy Pregnancy Category C. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection).

🧒 Pediatric Use 141 words ▾

8.4Pediatric Use INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years. INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates.

Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [ see Warnings and Precautions ( 5.1 ) ]. Additional vitamin E supplementations of infants receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity [ see Warnings and Precautions ( 5.8 ) ]. E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates which are found in INFUVITE PEDIATRIC.

No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported [ see Warnings and Precautions ( 5.10 ) ].

🆘 Overdosage 28 words ▾

10 OVERDOSAGE Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE PEDIATRIC component toxicity. There is no clinical experience with INFUVITE PEDIATRIC overdosage.

📦 How Supplied / Storage and Handling 168 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: INFUVITE PEDIATRIC (multiple vitamins injection) is supplied as follows: INFUVITE PEDIATRIC (multiple vitamins injection) Single Dose: • NDC 54643-9023-1 - Boxes containing ten single dose vials – five each of Vial 1 (4 mL) and five each of Vial 2 (1 mL), one Vial 1 plus one Vial 2 to be used for a single dose [ see Dosage and Administration ( 2.2 , 2.3 ) ] . INFUVITE PEDIATRIC (multiple vitamins injection) Pharmacy Bulk Package: • NDC 54643-9031-0 - Boxes containing two vials – Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL).

Mixed contents of Vial 2 with Vial 1 provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or 10 single 5 mL doses [see Dosage and Administration ( 2.2 , 2.3 )]. Storage and Handling: Minimize exposure of INFUVITE PEDIATRIC to light because vitamins A, D and riboflavin are light sensitive. Store under refrigeration 2° to 8°C (36° to 46°F).

📋 Description ~2 min read ▾

11 DESCRIPTION INFUVITE PEDIATRIC (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution: INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of: (a) Vial 1 (4 mL); and (b) Vial 2 (1 mL). Vial 1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [ see Dosage and Administration ( 2.2 ) ] .

INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of: (a) Vial 1 (40 mL Fill in 50 mL Vial); and (b) Vial 2 (10 mL). The mixed solution will provide many single doses [ see Dosage and Administration ( 2.2 ) ]. Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3).

Table 3: INGREDIENTS IN INFUVITE PEDIATRIC FORMULATION Vial 1 Active Ingredient Quantity per 4 mL Ascorbic acid (Vitamin C) 80 mg Vitamin A* (as palmitate) 2,300 IU (equals 0.7 mg) Vitamin D 3 * (cholecalciferol) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 1 mg Niacinamide 17 mg Dexpanthenol (as d -pantothenyl alcohol) 5 mg Vitamin E* ( dl -α-tocopheryl acetate) 7 IU (equals 7 mg) Vitamin K 1 * 0.2 mg *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.

Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. Vial 2 Active Ingredient Quantity per 1 mL Folic acid 140 mcg Biotin 20 mcg Vitamin B 12 (cyanocobalamin) 1 mcg Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. INFUVITE PEDIATRIC (multiple vitamins injection) makes available a combination of oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions.

The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials 1 and 2).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Instruct caregiver(s) and patients (if age appropriate): • To watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in INFUVITE PEDIATRIC. • To watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A. • To report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia. • Patients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted. • About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin A levels in patients with renal impairment. • That INFUVITE PEDIATRIC should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. • That vitamin C (ascorbic acid) contained in INFUVITE PEDIATRIC may cause false negative urine glucose results.

Manufactured by Sandoz Canada Inc. 145 Jules-Léger Street Boucherville, Qc, Canada, J4B 7K8 Distributed by Baxter Healthcare Corporation for NOVAPLUS ® Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada NOVAPLUS is a registered trademark of Vizient, Inc. ® INFUVITE is a registered trademark of Sandoz Canada Inc. 46194735 10-2016

🍼 Nursing Mothers 36 words ▾

8.3Nursing Mothers INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers.

🧪 Nonclinical Toxicology 21 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 18 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

📄 Package Label / Principal Display Panel 138 words ▾

Vials Carton NDC 54643-9023-1 2A9008NP INFUVITE ® PEDiatric Multiple Vitamins Injection Rx only For intravenous infusion after dilution only. STERILE Contains 5 each of Vial 1 (4 mL) and Vial 2 (1 mL). One vial of each to be used for a single dose. Vial 1 (4 mL) Vial 2 (1 mL) Store under refrigeration 2° to 8° C (36° to 46° F). NOVAPLUS ® Infuvite Pediatric Single Dose

Pharmacy Bulk Package Carton NDC 54643-9031-0 2A9061NP INFUVITE ® PEDiatric PHARMACY BULK PACKAGE Multiple Vitamins Injection Rx only STERILE PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Vial 1 (40 mL fill in 50 mL) Vial 2 (10 mL) Both vials combined produce 10 single doses. For intravenous infusion after dilution only. Store under refrigeration 2° to 8° C (36° to 46° F). NOVAPLUS ® Infuvite Adult Pharmacy Bulk Carton

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 Kit / multi-component package

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Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
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Questions about this listing

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 it is currently marketed — but Sandoz Inc has reported a marketing end date of 2026-10-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sandoz Inc 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.
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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.
← 54643-9023-01 · Sandoz 54660-0001-00 · Societe →
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.