Over-the-counter drug · NDA
Alli (Orlistat) NDC 71610-805
Orlistat 60 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-805-34 | 71610080534 | 2280 CAPSULE in 1 BOTTLE (71610-805-34)Marketed from Mar 22, 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)
- Alli
- Generic name (nonproprietary)
- orlistat
- Active ingredients
- Orlistat — 60 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-805_14a73146-26ef-3d96-e063-6394a90ab4ceSPL ID 14a73146-26ef-3d96-e063-6394a90ab4ceSPL set ID 14a75092-f910-53df-e063-6294a90acc66RxCUI 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
N471610080534followed by a unit qualifier and the quantityPackage 71610-0805-34. 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 71610-805
- What is NDC 71610-805?
- 71610-805 is the product NDC for Alli (orlistat), Orlistat 60 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 | Haleon US Holdings LLC | 0135-0461 | 00135-0461-0100135-0461-0500135-0461-06 |
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 | Haleon US Holdings LLC | 0135-0461 |