Prescription drug · ANDA
Alosetron Hydrochloride NDC 73190-035
Alosetron hydrochloride .5 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-035-30 | 73190003530 | 30 TABLET, FILM COATED in 1 BOTTLE (73190-035-30)Marketed from Jul 25, 2025 |
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
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206647
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 73190-035_3e64c1e9-713c-8f82-e063-6394a90a7bbbSPL ID 3e64c1e9-713c-8f82-e063-6394a90a7bbbSPL set ID 3ac203a2-4c55-deac-e063-6394a90aa165RxCUI 259306, 403975UNII 2F5R1A46YWUPC 0373190036303, 0373190035306
- 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
N473190003530followed by a unit qualifier and the quantityPackage 73190-0035-30. 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 . 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.
Other NDCs under ANDA 206647
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | 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 |
| Alosetron Hydrochloride | Alosetron hydrochloride .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-248 |