Prescription drug · ANDA
Enulose (Lactulose) NDC 63629-8800
Lactulose 10 g/15mL · Solution · Oral, Rectal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8800-1 | 6362988000163629880001 | 473 mL in 1 BOTTLE (63629-8800-1)Marketed from Sep 10, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Enulose
- Generic name (nonproprietary)
- lactulose
- Active ingredients
- Lactulose — 10 g/15mL
- Dosage form
- Solution
- Route
- Oral, Rectal
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090502
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 63629-8800_29413ce2-7389-4c44-a4b1-f424ac86024fSPL ID 29413ce2-7389-4c44-a4b1-f424ac86024fSPL set ID fa3aae7c-6f98-4fbb-85dc-32affe9874d5RxCUI 391937, 755470UNII 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
N463629880001followed by a unit qualifier and the quantityPackage 63629-8800-01. 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 levels 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 therapy. In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 ye…
Excerpt only. Read the full label for complete information.
About NDC 63629-8800
- What is NDC 63629-8800?
- 63629-8800 is the product NDC for Enulose (lactulose), Lactulose 10 g/15mL solution, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enulose (Lactulose).
- What is the active ingredient?
- Lactulose.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enulose?
- 1 other product NDC are listed under this name. See all Enulose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Enulose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Enuloselactulose | Lactulose 10 g/15mL | SolutionOral, Rectal | Actavis Pharma, Inc. | 45963-438 | 45963-0438-64 |
Other NDCs under ANDA 090502
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 |
|---|---|---|---|---|
| Enuloselactulose | Lactulose 10 g/15mL | SolutionOral, Rectal | Actavis Pharma, Inc. | 45963-438 |
| Lactulose | Lactulose 10 g/15mL | SolutionOral, Rectal | Fresenius Kabi Austria GmbH | 18124-002 |