Prescription drug · ANDA
Lactulose NDC 69067-020
Lactulose 20 g/20g · Solution · Oral · Foxland Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69067-020-15 | 69067002015 | 15 PACKET in 1 CARTON (69067-020-15) / 20 g in 1 PACKETMarketed from Feb 7, 2025 |
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 — 20 g/20g
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074712
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 69067-020_4618824a-2b40-3d54-e063-6394a90a4b96SPL ID 4618824a-2b40-3d54-e063-6394a90a4b96SPL set ID 3363bdbd-f0d1-45b3-8193-7fdb0a310cc2RxCUI 1251190, 1251194UNII 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
N469067002015followed by a unit qualifier and the quantityPackage 69067-0020-15. 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 LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose 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 074712
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 |
|---|---|---|---|---|
| Kristaloselactulose | Lactulose 10 g/10g | Powder, For solutionOral | Cumberland Pharmaceuticals Inc. | 66220-719 |
| Kristaloselactulose | Lactulose 20 g/20g | Powder, For solutionOral | Cumberland Pharmaceuticals Inc. | 66220-729 |
| Lactulose | Lactulose 10 g/10g | SolutionOral | Foxland Pharmaceuticals, Inc. | 69067-010 |
| LACTULOSE Crystallinelactulose | Lactulose 10 g/10g | Powder, For solutionOral | Cumberland Assured Products Inc. | 85592-819 |
| LACTULOSE Crystallinelactulose | Lactulose 20 g/20g | Powder, For solutionOral | Cumberland Assured Products Inc. | 85592-829 |