Over-the-counter drug · NDA
Alli (Orlistat) NDC 0135-0461
Orlistat 60 mg/1 · Capsule · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0461-01 | 00135046101 | 60 CAPSULE in 1 BOTTLE (0135-0461-01)Marketed from Sep 1, 2016 | |
| 0135-0461-05 | 00135046105 | 120 CAPSULE in 1 BOTTLE (0135-0461-05)Marketed from Feb 7, 2007 | |
| 0135-0461-06 | 00135046106 | 170 CAPSULE in 1 BOTTLE (0135-0461-06)Marketed from Feb 7, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Alli
- Generic name (nonproprietary)
- orlistat
- Active ingredients
- Orlistat — 60 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0135
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021887
- Marketing start
- Listing expires
- Other FDA classes
- Lipase Inhibitors (Mechanism)
- Identifiers
- Product ID 0135-0461_4d51b8f1-a819-7ff6-e063-6294a90a82bcSPL ID 4d51b8f1-a819-7ff6-e063-6294a90a82bcSPL set ID a2d3bd73-f3af-4ea5-a57c-66b0004cfe4fRxCUI 692876, 723846UNII 95M8R751W8
- Pharmacologic class
- Intestinal Lipase Inhibitor
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
N400135046101followed by a unit qualifier and the quantityPackage 00135-0461-01. 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)
Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Excerpt only. Read the full label for complete information.
About NDC 0135-0461
- What is NDC 0135-0461?
- 0135-0461 is the product NDC for Alli (orlistat), Orlistat 60 mg/1 capsule, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alli (Orlistat).
- What is the active ingredient?
- Orlistat.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alli?
- 1 other product NDC are listed under this name. See all Alli NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alli products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alliorlistat | Orlistat 60 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-805 | 71610-0805-34 |
Other NDCs under NDA 021887
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 |
|---|---|---|---|---|
| Alliorlistat | Orlistat 60 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-805 |