What is NDC 63629-2518?

63629-2518 is the product NDC for Alosetron, Alosetron hydrochloride 1 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alosetron?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alosetron NDC 63629-2518 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2518Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2518Add 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
63629-2518-1	6362925180163629251801	30 TABLET in 1 BOTTLE (63629-2518-1)Marketed from Mar 29, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Generic name (nonproprietary): alosetron
Active ingredients: Alosetron hydrochloride — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213614
Marketing start: Sep 14, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63629-2518_cd337c95-1e5a-4dfa-84f7-e668c93d8565SPL ID cd337c95-1e5a-4dfa-84f7-e668c93d8565SPL set ID 38f5341f-5ae3-46bf-8bfc-30dff2068477RxCUI 259306UNII 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

N463629251801 followed by a unit qualifier and the quantity

Package 63629-2518-01. 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 Apr 1, 2026. 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 with alosetron tablets, the indication is restricted to th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2518

What is NDC 63629-2518?: 63629-2518 is the product NDC for Alosetron, Alosetron hydrochloride 1 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alosetron.
What is the active ingredient?: Alosetron hydrochloride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alosetron?: 3 other product NDCs are listed under this name. See all Alosetron NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Alosetron NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alosetron	Alosetron hydrochloride .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-2517	63629-2517-01
Alosetron	Alosetron hydrochloride 1 mg/1	TabletOral	Lifestar Pharma LLC	70756-701	70756-0701-30
Alosetron	Alosetron hydrochloride .5 mg/1	TabletOral	Lifestar Pharma LLC	70756-702	70756-0702-30

Other NDCs under ANDA 213614

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

FDA NDC Directory listings under ANDA 213614
Product	Strength	Form · route	Labeler	Product NDC
Alosetron	Alosetron hydrochloride .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-2517
Alosetron	Alosetron hydrochloride 1 mg/1	TabletOral	Lifestar Pharma LLC	70756-701
Alosetron	Alosetron hydrochloride .5 mg/1	TabletOral	Lifestar Pharma LLC	70756-702