NDC codes

FDA NDC Directory
Product NDC (as listed)0941-0679Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00941-0679Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0941-0679-0500941067905009410679052500 mL in 1 BAG (0941-0679-05)Marketed from Dec 20, 2002
0941-0679-0600941067906009410679062000 mL in 1 BAG (0941-0679-06)Marketed from Dec 20, 2002
0941-0679-5200941067952009410679522000 mL in 1 BAG (0941-0679-52)Marketed from Dec 20, 2002
0941-0679-5300941067953009410679532500 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 LLCNDC labeler code 0941
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

N400941067905 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0941-0679

What is NDC 0941-0679?
0941-0679 is the product NDC for Extraneal, Icodextrin 7.5 g/100mL + 4 more ingredients injection, solution, listed with the FDA by Vantive US Healthcare LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Extraneal (Icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride).
What is the active ingredient?
Icodextrin, Sodium chloride, Sodium lactate, Calcium chloride, Magnesium chloride.
Who is the labeler?
Vantive US Healthcare LLC, NDC labeler code 0941. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Extraneal?
2 other product NDCs are listed under this name. See all Extraneal NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Extraneal NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Extranealicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideIcodextrin 7.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-070700941-0707-06
Extranealicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideIcodextrin 7.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-068100941-0681-08

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