Alosetron Hydrochloride NDC 65162-248

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-248Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0248Add 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
65162-248-03	65162024803	30 TABLET, FILM COATED in 1 BOTTLE (65162-248-03)Marketed from Jan 2, 2017
65162-248-50	65162024850	500 TABLET, FILM COATED in 1 BOTTLE (65162-248-50)Marketed from Jan 2, 2017

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): Alosetron Hydrochloride
Generic name (nonproprietary): alosetron hydrochloride
Active ingredients: Alosetron hydrochloride — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206647
Marketing start: Jan 2, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-248_c13f2cbc-86c6-4f24-8933-7219f6aa34bdSPL ID c13f2cbc-86c6-4f24-8933-7219f6aa34bdSPL set ID ba94ab71-11d7-4ce1-9b21-0b8c6a39e993RxCUI 259306, 403975UNII 2F5R1A46YW
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

N465162024803 followed by a unit qualifier and the quantity

Package 65162-0248-03. 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 May 23, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Alosetron tablets are 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 withalosetron tablets, the indication is restricted to tho…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206647

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

FDA NDC Directory listings under ANDA 206647
Product	Strength	Form · route	Labeler	Product NDC
Alosetron Hydrochloride	Alosetron hydrochloride 1 mg/1	Tablet, Film coatedOral	AvKARE	73190-036
Alosetron Hydrochloride	Alosetron hydrochloride .5 mg/1	Tablet, Film coatedOral	AvKARE	73190-035
Alosetron Hydrochloride	Alosetron hydrochloride .5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-248
Alosetron Hydrochloride	Alosetron hydrochloride 1 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-249
Alosetron Hydrochloride	Alosetron hydrochloride 1 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-249