Prescription drug · ANDA
Multiple Electrolytes pH 5.5 NDC 65219-387
Sodium chloride 526 mg/100mL + 4 more ingredients · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-387-05 | 65219038705 | 20 BAG in 1 CASE (65219-387-05) / 500 mL in 1 BAG (65219-387-00)Marketed from Oct 21, 2022 | |
| 65219-387-10 | 65219038710 | 10 BAG in 1 CASE (65219-387-10) / 1000 mL in 1 BAG (65219-387-02)Marketed from Oct 21, 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)
- Multiple Electrolytes pH 5.5
- Generic name (nonproprietary)
- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
- Active ingredients
- Sodium chloride — 526 mg/100mLSodium gluconate — 502 mg/100mLSodium acetate — 368 mg/100mLPotassium chloride — 37 mg/100mLMagnesium chloride — 30 mg/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 215370
- Marketing start
- Listing expires
- Other FDA classes
- 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)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 65219-387_847f9b87-ebe4-4ff7-89b7-bcee26ef1f49SPL ID 847f9b87-ebe4-4ff7-89b7-bcee26ef1f49SPL set ID cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5cRxCUI 801109UNII 451W47IQ8X, R6Q3791S76, 4550K0SC9B, 660YQ98I10, 02F3473H9O
- Pharmacologic class
- Calculi Dissolution Agent; Osmotic Laxative; 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
N465219038705followed by a unit qualifier and the quantityPackage 65219-0387-05. 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 Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.
Excerpt only. Read the full label for complete information.
About NDC 65219-387
- What is NDC 65219-387?
- 65219-387 is the product NDC for Multiple Electrolytes pH 5.5, Sodium chloride 526 mg/100mL + 4 more ingredients injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Multiple Electrolytes pH 5.5 (Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride).
- What is the active ingredient?
- Sodium chloride, Sodium gluconate, Sodium acetate, Potassium chloride, Magnesium chloride.
- 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 Multiple Electrolytes pH 5.5?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.