Prescription drug · ANDA
Lactulose NDC 82804-107
Lactulose 10 g/15mL · Solution · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-107-47 | 82804010747 | 473 mL in 1 BOTTLE (82804-107-47)Marketed from Jun 14, 2024 |
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
- Labeler
- Proficient Rx LP
- 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 82804-107_6bbabdc6-f6a8-4f67-a448-e452d1928debSPL ID 6bbabdc6-f6a8-4f67-a448-e452d1928debSPL set ID 6bbabdc6-f6a8-4f67-a448-e452d1928debRxCUI 391937UNII 9U7D5QH5AEUPC 0382804107476
- 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
N482804010747followed by a unit qualifier and the quantityPackage 82804-0107-47. 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 | Atlantic Biologicals Corp. | 17856-0874 |
| 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 |