Alli (orlistat) NDC 0135-0461

NDC codes

FDA NDC Directory

Product NDC (as listed)0135-0461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00135-0461Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
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 LLC
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021887
Marketing start: Feb 7, 2007
Listing expires: Dec 31, 2027
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

N400135046101 followed by a unit qualifier and the quantity

Package 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 Mar 18, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021887

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021887
Product	Strength	Form · route	Labeler	Product NDC
Alliorlistat	Orlistat 60 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-805