NDC codes

FDA NDC Directory
Product NDC (as listed)0941-0415Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00941-0415Add 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
0941-0415-01009410415016000 mL in 1 BAG (0941-0415-01)Marketed from Sep 27, 1978
0941-0415-04009410415043000 mL in 1 BAG (0941-0415-04)Marketed from Sep 27, 1978
0941-0415-05009410415051000 mL in 1 BAG (0941-0415-05)Marketed from Sep 28, 1978
0941-0415-06009410415062000 mL in 1 BAG (0941-0415-06)Marketed from Sep 27, 1978
0941-0415-07009410415075000 mL in 1 BAG (0941-0415-07)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 PD-2 with Dextrose
Generic name (nonproprietary)
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Active ingredients
Dextrose monohydrate — 4.25 g/100mLSodium chloride — 538 mg/100mLSodium lactate — 448 mg/100mLCalcium chloride — 25.7 mg/100mLMagnesium chloride — 5.08 mg/100mL
Dosage form
Injection, Solution
Route
Intraperitoneal
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017512
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 0941-0415_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 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

N400941041501 followed by a unit qualifier and the quantity

Package 00941-0415-01. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017512

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 017512
ProductStrengthForm · routeLabelerProduct NDC
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 2.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0457
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 4.25 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0459
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 1.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0484
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 2.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0487
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 4.25 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0490
DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 1.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0409
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 1.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0411
DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDextrose monohydrate 2.5 g/100mL + 4 more ingredientsInjection, SolutionIntraperitonealVantive US Healthcare LLC0941-0413

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