Prescription drug · NDA
Infuvite Pediatric (Multiple vitamins injection) NDC 54643-5646
Kit · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54643-5646-1 | 5464356460154643564601 | 1 KIT in 1 CARTON (54643-5646-1) * 4 mL in 1 VIAL (54643-5648-1) * 1 mL in 1 VIAL (54643-5651-1)Marketed from Feb 21, 2001 |
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)
- Infuvite Pediatric
- Generic name (nonproprietary)
- multiple vitamins injection
- Dosage form
- Kit
- Labeler
- Sandoz IncNDC labeler code 54643
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021265
- Marketing start
- Listing expires
- Identifiers
- Product ID 54643-5646_7af6954f-c80e-4673-b47d-457de4288becSPL ID 7af6954f-c80e-4673-b47d-457de4288becSPL set ID 6d06546e-8b0a-4490-82d9-397bd902a044RxCUI 1305217, 1305222
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.
- NDC on a medical claim
N454643564601followed by a unit qualifier and the quantityPackage 54643-5646-01. 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.
About NDC 54643-5646
- What is NDC 54643-5646?
- 54643-5646 is the product NDC for Infuvite Pediatric (multiple vitamins injection) kit, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Infuvite Pediatric (Multiple vitamins injection).
- Who is the labeler?
- Sandoz Inc, NDC labeler code 54643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Infuvite Pediatric?
- 1 other product NDC are listed under this name. See all Infuvite Pediatric NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Infuvite Pediatric products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Infuvite Pediatricmultiple vitamins injection | — | Kit | Sandoz Inc | 54643-5647 | 54643-5647-00 |
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 | 54643-5647 |
| Pediatric Infuvite Multiple Vitaminsascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin-5 phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin | Ascorbic acid 80 mg/5mL + 12 more ingredients | Injection, SolutionIntravenous | Sandoz Inc | 54643-9023 |