Prescription drug · ANDA
Dextrose and Sodium Chloride (Dextrose monohydrate and sodium chloride) NDC 63323-869
Dextrose monohydrate 5 g/100mL; Sodium chloride .45 g/100mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-869-10 | 6332308691063323086910 | 10 BAG in 1 CASE (63323-869-10) / 1000 mL in 1 BAG (63323-869-01)Marketed from Oct 26, 2020 | |
| 63323-869-74 | 6332308697463323086974 | 20 BAG in 1 CASE (63323-869-74) / 500 mL in 1 BAG (63323-869-04)Marketed from Oct 26, 2020 | |
| 63323-869-75 | 6332308697563323086975 | 30 BAG in 1 CASE (63323-869-75) / 250 mL in 1 BAG (63323-869-05)Marketed from Oct 26, 2020 |
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 and Sodium Chloride
- Generic name (nonproprietary)
- dextrose monohydrate and sodium chloride
- Active ingredients
- Dextrose monohydrate — 5 g/100mLSodium chloride — .45 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211276
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 63323-869_07c0fcbe-d4e6-4c20-b72c-5c217abafd7dSPL ID 07c0fcbe-d4e6-4c20-b72c-5c217abafd7dSPL set ID 3c5f0f65-8a54-4a55-ad4e-0f0be97631d7RxCUI 1795250, 1795252, 1795254UNII LX22YL083G, 451W47IQ8X
- Pharmacologic class
- Osmotic Laxative
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
N463323086910followed by a unit qualifier and the quantityPackage 63323-0869-10. 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 and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.
Excerpt only. Read the full label for complete information.
About NDC 63323-869
- What is NDC 63323-869?
- 63323-869 is the product NDC for Dextrose and Sodium Chloride, Dextrose monohydrate 5 g/100mL; Sodium chloride .45 g/100mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextrose and Sodium Chloride (DEXTROSE MONOHYDRATE and SODIUM CHLORIDE).
- What is the active ingredient?
- Dextrose monohydrate, Sodium chloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextrose and Sodium Chloride?
- 21 other product NDCs are listed under this name. See all Dextrose and Sodium Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextrose and Sodium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextrose And Sodium Chloridedextrose monohydrate, sodium chloride | Dextrose monohydrate 2.5 g/100mL; Sodium chloride .45 g/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-874 | 63323-0874-10 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .45 g/100mL | Injection, SolutionIntravenous | BECTON DICKINSON AND COMPANY | 17271-734 | 17271-0734-0517271-0734-0617271-0734-07 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .9 g/100mL | Injection, SolutionIntravenous | BECTON DICKINSON AND COMPANY | 17271-735 | 17271-0735-0617271-0735-07 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .3 g/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-867 | 63323-0867-1063323-0867-7463323-0867-75 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .9 g/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-870 | 63323-0870-1063323-0870-74 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .225 g/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-873 | 63323-0873-1063323-0873-7463323-0873-75 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .225 g/100mL | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7924 | 00990-7924-0200990-7924-0300990-7924-09 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .3 g/100mL | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7925 | 00990-7925-0300990-7925-09 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .45 g/100mL | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7926 | 00990-7926-0200990-7926-0300990-7926-09 |
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .9 g/100mL | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7941 | 00990-7941-0300990-7941-09 |
Other NDCs under ANDA 211276
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 |
|---|---|---|---|---|
| Dextrose and Sodium Chloridedextrose monohydrate and sodium chloride | Dextrose monohydrate 5 g/100mL; Sodium chloride .45 g/100mL | Injection, SolutionIntravenous | BECTON DICKINSON AND COMPANY | 17271-734 |