Prescription drug · NDA
DIANEAL Low Calcium with Dextrose NDC 0941-0484
Dextrose monohydrate 1.5 g/100mL + 4 more ingredients · Injection, Solution · Intraperitoneal · Vantive US Healthcare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0941-0484-01 | 00941048401 | 5000 mL in 1 BAG (0941-0484-01)Marketed from Sep 27, 1978 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- DIANEAL Low Calcium with Dextrose
- Generic name (nonproprietary)
- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
- Active ingredients
- Dextrose monohydrate — 1.5 g/100mLSodium chloride — 538 mg/100mLSodium lactate — 448 mg/100mLCalcium chloride — 18.4 mg/100mLMagnesium chloride — 5.08 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intraperitoneal
- Labeler
- Vantive US Healthcare LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017512
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (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 Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 0941-0484_194f41a6-655b-456a-955f-7566eb429b7bSPL ID 194f41a6-655b-456a-955f-7566eb429b7bSPL set ID aa268d3f-7389-4f25-801f-5d4825495f08RxCUI 799999, 800003, 800057, 800061, 800062, 800064, 800066, 800074, 800111, 800115, 800472, 800474UNII 451W47IQ8X, TU7HW0W0QT, LX22YL083G, 02F3473H9O, M4I0D6VV5M
- 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
N400941048401followed by a unit qualifier and the quantityPackage 00941-0484-01. 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)
DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. For management of acute or chronic renal failure.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017512
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 |
|---|---|---|---|---|
| DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 2.5 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0457 |
| DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 4.25 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0459 |
| DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 2.5 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0487 |
| DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 4.25 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0490 |
| DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 1.5 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0409 |
| DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 1.5 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0411 |
| DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 2.5 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0413 |
| DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Dextrose monohydrate 4.25 g/100mL + 4 more ingredients | Injection, SolutionIntraperitoneal | Vantive US Healthcare LLC | 0941-0415 |