Prescription drug · ANDA
Lactated Ringers and Dextrose NDC 65219-241
Sodium chloride 600 mg/100mL + 4 more ingredients · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-241-10 | 6521902411065219024110 | 10 BAG in 1 CASE (65219-241-10) / 1000 mL in 1 BAG (65219-241-00)Marketed from Mar 28, 2022 |
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)
- Lactated Ringers and Dextrose
- Generic name (nonproprietary)
- sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate
- Active ingredients
- Sodium chloride — 600 mg/100mLSodium lactate — 310 mg/100mLPotassium chloride — 30 mg/100mLCalcium chloride — 20 mg/100mLDextrose monohydrate — 5 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210332
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Potassium Compounds (Chemical structure)
- Identifiers
- Product ID 65219-241_b13e4afe-9bf1-4bf8-9674-e53ae5cb0fceSPL ID b13e4afe-9bf1-4bf8-9674-e53ae5cb0fceSPL set ID 1b912c7e-f005-4af4-b683-083440964249RxCUI 847627UNII LX22YL083G, TU7HW0W0QT, 660YQ98I10, M4I0D6VV5M, 451W47IQ8X
- Pharmacologic class
- Blood Coagulation Factor; Osmotic Laxative; Phosphate Binder; Potassium Salt
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
N465219024110followed by a unit qualifier and the quantityPackage 65219-0241-10. 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 These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories, as required by the clinical condition of the patient.
Excerpt only. Read the full label for complete information.
About NDC 65219-241
- What is NDC 65219-241?
- 65219-241 is the product NDC for Lactated Ringers and Dextrose, Sodium chloride 600 mg/100mL + 4 more ingredients injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lactated Ringers and Dextrose (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE).
- What is the active ingredient?
- Sodium chloride, Sodium lactate, Potassium chloride, Calcium chloride, Dextrose monohydrate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lactated Ringers and Dextrose?
- 4 other product NDCs are listed under this name. See all Lactated Ringers and Dextrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lactated Ringers and Dextrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lactated Ringers and Dextrosesodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate | Sodium chloride 600 mg/100mL + 4 more ingredients | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-243 | 65219-0243-50 |
| Lactated Ringers And Dextrosesodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate | Dextrose monohydrate 5 g/100mL + 4 more ingredients | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1521 | 51662-1521-01 |
| Lactated Ringers and Dextrosesodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate | Sodium chloride 600 mg/100mL + 4 more ingredients | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7929 | 00990-7929-0300990-7929-09 |
| Lactated Ringers and Dextrosesodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose monohydrate | Dextrose monohydrate 5 g/100mL + 4 more ingredients | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0125 | 00338-0125-0300338-0125-04 |
Other NDCs under ANDA 210332
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 |
|---|---|---|---|---|
| Lactated Ringers and Dextrosesodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate | Sodium chloride 600 mg/100mL + 4 more ingredients | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-243 |