Prescription drug · NDA
Extraneal NDC 0941-0679
Icodextrin 7.5 g/100mL + 4 more ingredients · Injection, Solution · Intraperitoneal · Vantive US Healthcare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0941-0679-05 | 00941067905 | 2500 mL in 1 BAG (0941-0679-05)Marketed from Dec 20, 2002 | |
| 0941-0679-06 | 00941067906 | 2000 mL in 1 BAG (0941-0679-06)Marketed from Dec 20, 2002 | |
| 0941-0679-52 | 00941067952 | 2000 mL in 1 BAG (0941-0679-52)Marketed from Dec 20, 2002 | |
| 0941-0679-53 | 00941067953 | 2500 mL in 1 BAG (0941-0679-53)Marketed from Dec 20, 2002 |
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)
- Extraneal
- Generic name (nonproprietary)
- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
- Active ingredients
- Icodextrin — 7.5 g/100mLSodium chloride — 535 mg/100mLSodium lactate — 448 mg/100mLCalcium chloride — 25.7 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 021321
- 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 0941-0679_8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1SPL ID 8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1SPL set ID d5b85158-b0d6-4855-9d07-8d1b3ad9ab71RxCUI 1100742, 1100746UNII 2NX48Z0A9G, 451W47IQ8X, TU7HW0W0QT, M4I0D6VV5M, 02F3473H9O
- 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
N400941067905followed by a unit qualifier and the quantityPackage 00941-0679-05. 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)
EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology ( 12 ), Clinical Studies ( 14 )]. • For a single daily exchange for the long (8- to 16- hour) dwell during continuo…
Excerpt only. Read the full label for complete information.