What is NDC 0527-5125?

0527-5125 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Lannett Company, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. 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 0527-5125 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-5125Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-5125Add 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
0527-5125-68	0052751256800527512568	237 mL in 1 BOTTLE (0527-5125-68)Marketed from Jul 26, 2001
0527-5125-70	0052751257000527512570	473 mL in 1 BOTTLE (0527-5125-70)Marketed from Jul 26, 2001
0527-5125-78	0052751257800527512578	946 mL in 1 BOTTLE (0527-5125-78)Marketed from Jul 26, 2001
0527-5125-82	0052751258200527512582	1892 mL in 1 BOTTLE (0527-5125-82)Marketed from Jul 26, 2001

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): Lactulose
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075993
Marketing start: Jul 26, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 0527-5125_1b869904-b3c5-4f81-a333-1f26b6b2c7bfSPL ID 1b869904-b3c5-4f81-a333-1f26b6b2c7bfSPL set ID 6619b25c-26b7-4c43-8c4f-9d33a23c61caRxCUI 391937UNII 9U7D5QH5AEUPC 0305275125701
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400527512568 followed by a unit qualifier and the quantity

Package 00527-5125-68. 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 Jan 30, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0527-5125

What is NDC 0527-5125?: 0527-5125 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Lannett Company, Inc.. It has 4 package NDCs, 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?: Lannett Company, Inc., NDC labeler code 0527. 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