Prescription drug · NDA
Delflex NDC 46163-212
Dextrose monohydrate 4.25 g/100mL + 4 more ingredients · Solution · Intraperitoneal · Fresenius Medical Care de Mexico, S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46163-212-92 | 46163021292 | 5 BAG in 1 CARTON (46163-212-92) / 2000 mL in 1 BAGMarketed from Aug 29, 2024 | |
| 46163-212-94 | 46163021294 | 5 BAG in 1 CARTON (46163-212-94) / 2500 mL in 1 BAGMarketed from Aug 29, 2024 | |
| 46163-212-95 | 46163021295 | 5 BAG in 1 CARTON (46163-212-95) / 2000 mL in 1 BAGMarketed from Aug 29, 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)
- Delflex
- Generic name (nonproprietary)
- dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
- Active ingredients
- Dextrose monohydrate — 4.25 g/100mLSodium chloride — 538 mg/100mLSodium lactate — 448 mg/100mLCalcium chloride — 18.4 mg/100mLMagnesium chloride — 5.08 mg/100mL
- Dosage form
- Solution
- Route
- Intraperitoneal
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020171
- 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)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 46163-212_579dba0f-f820-8f9a-e063-6294a90a76b0SPL ID 579dba0f-f820-8f9a-e063-6294a90a76b0SPL set ID a98facd6-9daa-4d37-8209-63a0599dbfaaUNII M4I0D6VV5M, TU7HW0W0QT, LX22YL083G, 02F3473H9O, 451W47IQ8X
- Pharmacologic class
- Blood Coagulation Factor; Calculi Dissolution Agent; Osmotic Laxative; Phosphate Binder
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
N446163021292followed by a unit qualifier and the quantityPackage 46163-0212-92. 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)
1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure patients being maintained on peritoneal dialysis For treatment of chronic kidney failure. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020171
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 |
|---|---|---|---|---|
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Dextrose monohydrate 1.5 g/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care Renal Therapies Group, LLC | 49230-206 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Dextrose monohydrate 1.5 g/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care Renal Therapies Group, LLC | 49230-206 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Dextrose monohydrate 4.25 g/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care Renal Therapies Group, LLC | 49230-212 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Sodium chloride 538 mg/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care Renal Therapies Group, LLC | 49230-209 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Dextrose monohydrate 2.5 g/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care Renal Therapies Group, LLC | 49230-209 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Dextrose monohydrate 4.25 g/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care Renal Therapies Group, LLC | 49230-212 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Dextrose monohydrate 1.5 g/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care de Mexico, S.A. de C.V. | 46163-206 |
| Delflexdextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride | Sodium chloride 538 mg/100mL + 4 more ingredients | SolutionIntraperitoneal | Fresenius Medical Care de Mexico, S.A. de C.V. | 46163-209 |