Prescription drug · NDA
Pediatric Infuvite Multiple Vitamins NDC 54643-9023
Ascorbic acid 80 mg/5mL + 12 more ingredients · Injection, Solution · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54643-9023-1 | 54643902301 | 10 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.
- NDC on a medical claim
N454643902301followed by a unit qualifier and the quantityPackage 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.
Other NDCs under NDA 021265
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Infuvite Pediatricmultiple vitamins injection | — | Kit | Sandoz Inc | 54643-5646 |
| Infuvite Pediatricmultiple vitamins injection | — | Kit | Sandoz Inc | 54643-5647 |