Prescription drug · ANDA
LACTULOSE Crystalline (Lactulose) NDC 85592-819
Lactulose 10 g/10g · Powder, For solution · Oral · Cumberland Assured Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85592-819-30 | 8559208193085592081930 | 30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01)Marketed from Sep 1, 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 CrystallineSuffix: Crystalline
- Generic name (nonproprietary)
- lactulose
- Active ingredients
- Lactulose — 10 g/10g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Cumberland Assured Products Inc.NDC labeler code 85592
- 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 85592-819_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9SPL ID ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9SPL set ID 59e75426-42ae-4904-941f-009181101a8aRxCUI 1251190, 1251194UNII 9U7D5QH5AEUPC 0385592829018, 0385592819019
- 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
N485592081930followed by a unit qualifier and the quantityPackage 85592-0819-30. 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.
About NDC 85592-819
- What is NDC 85592-819?
- 85592-819 is the product NDC for LACTULOSE Crystalline (lactulose), Lactulose 10 g/10g powder, for solution, listed with the FDA by Cumberland Assured Products Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- LACTULOSE Crystalline (Lactulose).
- What is the active ingredient?
- Lactulose.
- Who is the labeler?
- Cumberland Assured Products Inc., NDC labeler code 85592. 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 Crystalline?
- 1 other product NDC are listed under this name. See all LACTULOSE Crystalline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other LACTULOSE Crystalline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| LACTULOSE Crystallinelactulose | Lactulose 20 g/20g | Powder, For solutionOral | Cumberland Assured Products Inc. | 85592-829 | 85592-0829-30 |
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 | Lactulose 20 g/20g | SolutionOral | Foxland Pharmaceuticals, Inc. | 69067-020 |
| LACTULOSE Crystallinelactulose | Lactulose 20 g/20g | Powder, For solutionOral | Cumberland Assured Products Inc. | 85592-829 |