Prescription drug · ANDA
Lactulose Solution (Lactulose solution usp, 10 g/15 ml) NDC 61037-471
Lactulose 10 g/15mL · Solution · Oral, Rectal · Bajaj Medical, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61037-471-02 | 6103704710261037047102 | 236 mL in 1 BOTTLE (61037-471-02)Marketed from Oct 14, 2021 | |
| 61037-471-03 | 6103704710361037047103 | 946 mL in 1 BOTTLE (61037-471-03)Marketed from Oct 14, 2021 | |
| 61037-471-04 | 6103704710461037047104 | 1893 mL in 1 JUG (61037-471-04)Marketed from Oct 14, 2021 | |
| 61037-471-05 | 6103704710561037047105 | 15 mL in 1 CUP, UNIT-DOSE (61037-471-05)Marketed from Oct 14, 2021 | |
| 61037-471-06 | 6103704710661037047106 | 3785 mL in 1 JUG (61037-471-06)Marketed from Oct 14, 2021 | |
| 61037-471-12 | 6103704711261037047112 | 473 mL in 1 BOTTLE (61037-471-12)Marketed from Oct 14, 2021 | |
| 61037-471-13 | 6103704711361037047113 | 118 mL in 1 BOTTLE (61037-471-13)Marketed from Oct 14, 2021 | |
| 61037-471-14 | 6103704711461037047114 | 30 mL in 1 CUP, UNIT-DOSE (61037-471-14)Marketed from Oct 14, 2021 |
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
- Bajaj Medical, LLCNDC labeler code 61037
- 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 61037-471_f0b79991-a87f-2b4b-e053-2995a90a8690SPL ID f0b79991-a87f-2b4b-e053-2995a90a8690SPL set ID d460b1a2-9091-2ac9-e053-2995a90aa1d2RxCUI 391937UNII 9U7D5QH5AEUPC 0361037471059, 0361037471042, 0361037471066, 0361037471141, 0361037471035, 0361037471127
- 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
N461037047102followed by a unit qualifier and the quantityPackage 61037-0471-02. 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 61037-471
- What is NDC 61037-471?
- 61037-471 is the product NDC for Lactulose Solution, Lactulose 10 g/15mL solution, listed with the FDA by Bajaj Medical, LLC. It has 8 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?
- Bajaj Medical, LLC, NDC labeler code 61037. 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 | Rising Pharma Holdings, Inc. | 64980-592 | 64980-0592-1264980-0592-2464980-0592-48+1 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 | Rising Pharma Holdings, Inc. | 64980-592 |
| Lactulose Solutionlactulose solution usp, 10 g/15 ml | Lactulose 10 g/15mL | SolutionOral, Rectal | Kesin Pharma Corporation | 81033-241 |