Prescription drug · ANDA
Lactulose Solution (Lactulose solution usp, 10 g/15 ml) NDC 64980-592
Lactulose 10 g/15mL · Solution · Oral, Rectal · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-592-12 | 6498005921264980059212 | 118 mL in 1 BOTTLE (64980-592-12)Marketed from May 25, 2023 | |
| 64980-592-24 | 6498005922464980059224 | 236 mL in 1 BOTTLE (64980-592-24)Marketed from May 25, 2023 | |
| 64980-592-48 | 6498005924864980059248 | 473 mL in 1 BOTTLE (64980-592-48)Marketed from May 25, 2023 | |
| 64980-592-95 | 6498005929564980059295 | 946 mL in 1 BOTTLE (64980-592-95)Marketed from May 25, 2023 |
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 Solution
- Generic name (nonproprietary)
- lactulose solution usp, 10 g/15 ml
- Active ingredients
- Lactulose — 10 g/15mL
- Dosage form
- Solution
- Route
- Oral, Rectal
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076645
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 64980-592_ae4387e8-ba31-4378-9e67-98effdcc998fSPL ID ae4387e8-ba31-4378-9e67-98effdcc998fSPL set ID e75c335b-f19e-42e2-a24f-d891a52d3d34RxCUI 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N464980059212followed by a unit qualifier and the quantityPackage 64980-0592-12. 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 prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia level by 25 to 50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been gi…
Excerpt only. Read the full label for complete information.
About NDC 64980-592
- What is NDC 64980-592?
- 64980-592 is the product NDC for Lactulose Solution, Lactulose 10 g/15mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lactulose Solution (Lactulose Solution USP, 10 g/15 mL).
- What is the active ingredient?
- Lactulose.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 Solution?
- 2 other product NDCs are listed under this name. See all Lactulose Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lactulose Solution 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 Solutionlactulose solution usp, 10 g/15 ml | Lactulose 10 g/15mL | SolutionOral, Rectal | Bajaj Medical, LLC | 61037-471 | 61037-0471-0261037-0471-0361037-0471-04+5 more |
| Lactulose Solutionlactulose solution usp, 10 g/15 ml | Lactulose 10 g/15mL | SolutionOral, Rectal | Kesin Pharma Corporation | 81033-241 | 81033-0241-32 |
Other NDCs under ANDA 076645
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 Solutionlactulose solution usp, 10 g/15 ml | Lactulose 10 g/15mL | SolutionOral, Rectal | Bajaj Medical, LLC | 61037-471 |
| Lactulose Solutionlactulose solution usp, 10 g/15 ml | Lactulose 10 g/15mL | SolutionOral, Rectal | Kesin Pharma Corporation | 81033-241 |