Lotronex (alosetron hydrochloride) NDC 54766-895

NDC codes

FDA NDC Directory

Product NDC (as listed)54766-895Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54766-0895Add 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
54766-895-03	54766089503	30 TABLET in 1 BOTTLE (54766-895-03)Marketed from Jul 11, 2016

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): Lotronex
Generic name (nonproprietary): alosetron hydrochloride
Active ingredients: Alosetron hydrochloride — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sebela Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021107
Marketing start: Jul 11, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 54766-895_557ed953-bb9c-8e24-e063-6394a90a525fSPL ID 557ed953-bb9c-8e24-e063-6394a90a525fSPL set ID 35cbb9d5-639b-207a-e054-00144ff88e88RxCUI 259306, 261362, 403975, 540181UNII 2F5R1A46YWUPC 0354766894039, 0354766895036
Pharmacologic class: Serotonin-3 Receptor Antagonist

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

N454766089503 followed by a unit qualifier and the quantity

Package 54766-0895-03. 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 Jun 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to IBS. Because of infrequent but serious gastrointestinal adverse reactions associated with LOTRONEX, the indication is restricted to those patients for wh…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021107

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

FDA NDC Directory listings under NDA 021107
Product	Strength	Form · route	Labeler	Product NDC
Lotronexalosetron hydrochloride	Alosetron hydrochloride .5 mg/1	TabletOral	Sebela Pharmaceuticals Inc.	54766-894
Lotronexalosetron hydrochloride	Alosetron hydrochloride .5 mg/1	TabletOral	Legacy Pharma USA Inc.	83107-013
Lotronexalosetron hydrochloride	Alosetron hydrochloride 1 mg/1	TabletOral	Legacy Pharma USA Inc.	83107-012