What is NDC 61269-565?

61269-565 is the product NDC for 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 Orlistat?

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.

Orlistat NDC 61269-565 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61269-565Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61269-0565Add 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
61269-565-90	6126905659061269056590	90 CAPSULE in 1 BOTTLE, PLASTIC (61269-565-90)Marketed from Jun 1, 2022

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): Orlistat
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 authorized genericApplication NDA 020766
Marketing start: Jun 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Lipase Inhibitors (Mechanism)
Identifiers: Product ID 61269-565_45add4e4-7806-4a6c-b360-e6e383d7e18eSPL ID 45add4e4-7806-4a6c-b360-e6e383d7e18eSPL set ID f81dfaeb-46d5-47ce-9ef6-19259f5ac61cRxCUI 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

N461269056590 followed by a unit qualifier and the quantity

Package 61269-0565-90. 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)

ORLISTAT is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. ORLISTAT is also indicated to reduce the risk for weight regain after prior weight loss. ORLISTAT 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 (BM…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61269-565

What is NDC 61269-565?: 61269-565 is the product NDC for 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?: 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 Orlistat?: 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
Xenicalorlistat	Orlistat 120 mg/1	CapsuleOral	H2-Pharma LLC	61269-460