What is NDC 61269-460?

61269-460 is the product NDC for Xenical (orlistat), Orlistat 120 mg/1 capsule, listed with the FDA by H2-Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

H2-Pharma LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xenical?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Xenical NDC 61269-460 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61269-460Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61269-0460Add 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	Copy
61269-460-90	6126904609061269046090	90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)Marketed from Dec 17, 2010

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): Xenical
Generic name (nonproprietary): orlistat
Active ingredients: Orlistat — 120 mg/1
Dosage form: Capsule
Route: Oral
Labeler: H2-Pharma LLCNDC labeler code 61269
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020766
Marketing start: Dec 17, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Lipase Inhibitors (Mechanism)
Identifiers: Product ID 61269-460_4fd710c5-6147-498a-ade9-0cce6e1513c7SPL ID 4fd710c5-6147-498a-ade9-0cce6e1513c7SPL set ID 6240792b-9224-2d10-e053-2a91aa0a2c3eRxCUI 226917, 314153UNII 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

N461269046090 followed by a unit qualifier and the quantity

Package 61269-0460-90. 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 Jan 9, 2026.

Indications (excerpt from the label)

XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m 2 or ≥27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). Table 1 illustrates body mass index (BMI) according to a variety of weights and heights. The BMI is calculated by dividing weight in kilograms by height in meters squared. For example, a person who weighs 180 lbs and is 5 ' 5 " would have a BMI of 30. Table 1 Body Mass Index (BMI),…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61269-460

What is NDC 61269-460?: 61269-460 is the product NDC for Xenical (orlistat), Orlistat 120 mg/1 capsule, listed with the FDA by H2-Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xenical (Orlistat).
What is the active ingredient?: Orlistat.
Who is the labeler?: H2-Pharma LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xenical?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 020766

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

FDA NDC Directory listings under NDA 020766
Product	Strength	Form · route	Labeler	Product NDC
Orlistat	Orlistat 120 mg/1	CapsuleOral	H2-Pharma LLC	61269-565

Xenical (Orlistat) NDC 61269-460