Prescription drug · ANDA
Dextrose (dextrose monohydrate) NDC 65219-464
Dextrose monohydrate 50 mg/mL · Injection, Solution · Intravenous · FRESENIUS KABI USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-464-50 | 65219046450 | 50 BAG in 1 CASE (65219-464-50) / 100 mL in 1 BAG (65219-464-05)Marketed from Jul 9, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Dextrose
- Generic name (nonproprietary)
- dextrose monohydrate
- Active ingredients
- Dextrose monohydrate — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- FRESENIUS KABI USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207449
- Marketing start
- Listing expires
- Identifiers
- Product ID 65219-464_efc3b0c9-518a-47db-bb3e-ebdfd4646e9bSPL ID efc3b0c9-518a-47db-bb3e-ebdfd4646e9bSPL set ID 576a22d8-5f2f-497e-80ad-1842ca74bb53RxCUI 1795607, 1795609, 1795610, 1795612, 1795616UNII LX22YL083G
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
N465219046450followed by a unit qualifier and the quantityPackage 65219-0464-50. 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)
INDICATIONS AND USAGE: Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207449
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 |
|---|---|---|---|---|
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-624 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 2500 mg/50mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-234 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 25000 mg/500mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-240 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 5000 mg/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-236 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 12500 mg/250mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-238 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | Becton Dickinson and Company | 17271-720 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 2500 mg/50mL | Injection, SolutionIntravenous | BECTON DICKINSON AND COMPANY | 17271-772 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-458 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-456 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-460 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-462 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-460 |