Lactulose NDC 0527-5125

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	00527512568	237 mL in 1 BOTTLE (0527-5125-68)Marketed from Jul 26, 2001
0527-5125-70	00527512570	473 mL in 1 BOTTLE (0527-5125-70)Marketed from Jul 26, 2001
0527-5125-78	00527512578	946 mL in 1 BOTTLE (0527-5125-78)Marketed from Jul 26, 2001
0527-5125-82	00527512582	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.
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

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