Prescription drug · ANDA
Lactulose NDC 62135-002
Lactulose 10 g/15mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-002-24 | 6213500022462135000224 | 2 TRAY in 1 BOX (62135-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (62135-002-51)Marketed from Mar 19, 2024 | |
| 62135-002-37 | 6213500023762135000237 | 237 mL in 1 PACKAGE (62135-002-37)Marketed from Mar 19, 2024 | |
| 62135-002-47 | 6213500024762135000247 | 473 mL in 1 PACKAGE (62135-002-47)Marketed from Mar 19, 2024 | |
| 62135-002-78 | 6213500027862135000278 | 3785 mL in 1 PACKAGE (62135-002-78)Marketed from Mar 19, 2024 | |
| 62135-002-94 | 6213500029462135000294 | 946 mL in 1 PACKAGE (62135-002-94)Marketed from Mar 19, 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
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209517
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 62135-002_49798265-6d70-8bc1-e063-6394a90a59d4SPL ID 49798265-6d70-8bc1-e063-6394a90a59d4SPL set ID d6975cd8-80e0-43e2-809a-175ea7e40715RxCUI 391937UNII 9U7D5QH5AEUPC 0362135002947, 0362135002374, 0362135002473, 0362135002787
- 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
N462135000224followed by a unit qualifier and the quantityPackage 62135-0002-24. 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)
INDICATION 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.
About NDC 62135-002
- What is NDC 62135-002?
- 62135-002 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Chartwell RX, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lactulose.
- What is the active ingredient?
- Lactulose.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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?
- 24 other product NDCs are listed under this name. See all Lactulose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lactulose 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 | Lactulose 10 g/15mL | SolutionOral | American Health Packaging | 60687-917 | 60687-0917-1460687-0917-6460687-0917-76 |
| Lactulose | Lactulose 10 g/10g | Powder, For solutionOral | Trifluent Pharma, Inc. | 73352-900 | 73352-0900-15 |
| Lactulose | Lactulose 20 g/20g | Powder, For solutionOral | Trifluent Pharma, Inc. | 73352-905 | 73352-0905-15 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-4243 | 51672-4243-09 |
| Lactulose | Lactulose 10 g/10g | Powder, For solutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0965 | 00121-0965-30 |
| Lactulose | Lactulose 20 g/20g | Powder, For solutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1930 | 00121-1930-30 |
| Lactulose | Lactulose 20 g/20g | SolutionOral | Foxland Pharmaceuticals, Inc. | 69067-020 | 69067-0020-15 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral, Rectal | APOZEAL PHARMACEUTICALS INC | 83745-249 | 83745-0249-0883745-0249-1683745-0249-32 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | APOZEAL PHARMACEUTICALS INC | 83745-405 | 83745-0405-1683745-0405-32 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | Xttrium Laboratories, Inc. | 0116-4005 | 00116-4005-0800116-4005-1000116-4005-11+4 more |
Other NDCs under ANDA 209517
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 | Chartwell RX, LLC. | 62135-003 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | Chartwell RX, LLC | 62135-004 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-002 |
| Lactulose | Lactulose 20 g/30mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-004 |