NDC codes

FDA NDC Directory
Product NDC (as listed)54643-9023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54643-9023Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
54643-9023-15464390230110 VIAL in 1 CARTON (54643-9023-1) / 5 mL in 1 VIALMarketed from Dec 23, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Pediatric Infuvite Multiple Vitamins
Generic name (nonproprietary)
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
Active ingredients
Ascorbic acid — 80 mg/5mLVitamin a palmitate — 2300 [iU]/5mLCholecalciferol — 400 [iU]/5mLThiamine hydrochloride — 1.2 mg/5mLRiboflavin 5'-phosphate sodium — 1.4 mg/5mLPyridoxine hydrochloride — 1 mg/5mLNiacinamide — 17 mg/5mLDexpanthenol — 5 mg/5mL.alpha.-tocopherol acetate — 7 [iU]/5mLPhytonadione — .2 mg/5mLFolic acid — 140 ug/5mLBiotin — 20 ug/5mLCyanocobalamin — 1 ug/5mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021265
Marketing start
Marketing end
Other FDA classes
Analogs/Derivatives (Chemical/Ingredient)Ascorbic Acid (Chemical structure)Increased Prothrombin Activity (Physiologic effect)Photoabsorption (Mechanism)Photosensitizing Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin A (Chemical structure)Vitamin B 12 (Chemical structure)Vitamin B 6 (Chemical/Ingredient)Vitamin D (Chemical structure)Vitamin K (Chemical structure)
Identifiers
Product ID 54643-9023_447b597f-d7fe-4489-b755-9929b40032f4SPL ID 447b597f-d7fe-4489-b755-9929b40032f4SPL set ID 4ff223f7-e076-4e81-8151-5c06724fabd9RxCUI 1305217, 1305222UNII PQ6CK8PD0R, 1D1K0N0VVC, 1C6V77QF41, M572600E5P, 20RD1DZH99, 68Y4CF58BV, 25X51I8RD4, 1O6C93RI7Z, 9E8X80D2L0, A034SE7857, 935E97BOY8, 6SO6U10H04, P6YC3EG204
Pharmacologic class
Photoenhancer; Vitamin A; Vitamin B12; Vitamin B6 Analog; Vitamin C; Vitamin D; Vitamin K; Warfarin Reversal Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N454643902301 followed by a unit qualifier and the quantity

Package 54643-9023-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021265

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021265
ProductStrengthForm · routeLabelerProduct NDC
Infuvite Pediatricmultiple vitamins injection—KitSandoz Inc54643-5646
Infuvite Pediatricmultiple vitamins injection—KitSandoz Inc54643-5647

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