What is NDC 18124-002?

18124-002 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Fresenius Kabi Austria GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi Austria GmbH, NDC labeler code 18124. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lactulose?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lactulose NDC 18124-002 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)18124-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width18124-0002Add 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 NDC	11-digit (billing)	Package	Copy
18124-002-16	1812400021618124000216	473 mL in 1 BOTTLE (18124-002-16)Marketed from Dec 10, 2012

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): Lactulose
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral, Rectal
Labeler: Fresenius Kabi Austria GmbHNDC labeler code 18124
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090502
Marketing start: Dec 10, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 18124-002_d95ab755-1c2e-4124-8ed7-075936257c25SPL ID d95ab755-1c2e-4124-8ed7-075936257c25SPL set ID a89835c9-8ce5-4627-8d7d-70ff175b2e07RxCUI 391937UNII 9U7D5QH5AE
Pharmacologic class: Osmotic Laxative

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

N418124000216 followed by a unit qualifier and the quantity

Package 18124-0002-16. 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 Nov 9, 2022.

Indications (excerpt from the label)

For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 years in controlled stud…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 18124-002

What is NDC 18124-002?: 18124-002 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Fresenius Kabi Austria GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lactulose.
What is the active ingredient?: Lactulose.
Who is the labeler?: Fresenius Kabi Austria GmbH, NDC labeler code 18124. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lactulose?: 24 other product NDCs are listed under this name. See all Lactulose 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 Lactulose NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lactulose	Lactulose 10 g/15mL	SolutionOral	American Health Packaging	60687-917	60687-0917-1460687-0917-6460687-0917-76
Lactulose	Lactulose 10 g/10g	Powder, For solutionOral	Trifluent Pharma, Inc.	73352-900	73352-0900-15
Lactulose	Lactulose 20 g/20g	Powder, For solutionOral	Trifluent Pharma, Inc.	73352-905	73352-0905-15
Lactulose	Lactulose 10 g/15mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	51672-4243	51672-4243-09
Lactulose	Lactulose 10 g/10g	Powder, For solutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0965	00121-0965-30
Lactulose	Lactulose 20 g/20g	Powder, For solutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1930	00121-1930-30
Lactulose	Lactulose 20 g/20g	SolutionOral	Foxland Pharmaceuticals, Inc.	69067-020	69067-0020-15
Lactulose	Lactulose 10 g/15mL	SolutionOral, Rectal	APOZEAL PHARMACEUTICALS INC	83745-249	83745-0249-0883745-0249-1683745-0249-32
Lactulose	Lactulose 10 g/15mL	SolutionOral	APOZEAL PHARMACEUTICALS INC	83745-405	83745-0405-1683745-0405-32
Lactulose	Lactulose 10 g/15mL	SolutionOral	Xttrium Laboratories, Inc.	0116-4005	00116-4005-0800116-4005-1000116-4005-11+4 more

All 25 Lactulose NDCs

Other NDCs under ANDA 090502

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

FDA NDC Directory listings under ANDA 090502
Product	Strength	Form · route	Labeler	Product NDC
Enuloselactulose	Lactulose 10 g/15mL	SolutionOral, Rectal	Actavis Pharma, Inc.	45963-438
Enuloselactulose	Lactulose 10 g/15mL	SolutionOral, Rectal	Bryant Ranch Prepack	63629-8800