Prescription drug · ANDA
Lactulose NDC 17856-0874
Lactulose 10 g/15mL · Solution · Oral · Atlantic Biologicals Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0874-3 | 17856087403 | 50 CUP, UNIT-DOSE in 1 CASE (17856-0874-3) / 30 mL in 1 CUP, UNIT-DOSEMarketed from Sep 26, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Atlantic Biologicals Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074623
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 17856-0874_3fb6eaf7-8029-7a5c-e063-6294a90a6889SPL ID 3fb6eaf7-8029-7a5c-e063-6294a90a6889SPL set ID 3fb6e908-893c-5a57-e063-6294a90a1bfcRxCUI 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 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
N417856087403followed by a unit qualifier and the quantityPackage 17856-0874-03. 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)
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.
Other NDCs under ANDA 074623
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lactulose | Lactulose 10 g/15mL | SolutionOral | Proficient Rx LP | 82804-107 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0873 |
| Lactulose | Lactulose 20 g/30mL | SolutionOral | Cardinal Health 107, LLC | 55154-9448 |
| Lactulose | Lactulose 20 g/30mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1746 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4577 |
| Lactulose | Lactulose 20 g/30mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1154 |