Prescription drug · ANDA
Alosetron Hydrochloride NDC 65162-249
Alosetron hydrochloride 1 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-249-03 | 6516202490365162024903 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-249-03)Marketed from Jan 2, 2017 | |
| 65162-249-50 | 6516202495065162024950 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-249-50)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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- 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 65162-249_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
N465162024903followed by a unit qualifier and the quantityPackage 65162-0249-03. 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 . 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.
About NDC 65162-249
- What is NDC 65162-249?
- 65162-249 is the product NDC for Alosetron Hydrochloride, Alosetron hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alosetron Hydrochloride.
- What is the active ingredient?
- Alosetron hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 Hydrochloride?
- 7 other product NDCs are listed under this name. See all Alosetron Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alosetron Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alosetron Hydrochloride | Alosetron hydrochloride .5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-035 | 73190-0035-30 |
| Alosetron Hydrochloride | Alosetron hydrochloride 1 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-036 | 73190-0036-30 |
| Alosetron Hydrochloride | Alosetron hydrochloride .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-248 | 53746-0248-30 |
| Alosetron Hydrochloride | Alosetron hydrochloride 1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-249 | 53746-0249-30 |
| Alosetron Hydrochloride | Alosetron hydrochloride .5 mg/1 | TabletOral | Eywa Pharma Inc | 71930-010 | 71930-0010-30 |
| Alosetron Hydrochloride | Alosetron hydrochloride 1 mg/1 | TabletOral | Eywa Pharma Inc | 71930-011 | 71930-0011-30 |
| Alosetron Hydrochloride | Alosetron hydrochloride .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-248 | 65162-0248-0365162-0248-50 |
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 .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 .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-248 |
| Alosetron Hydrochloride | Alosetron hydrochloride .5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-035 |
| Alosetron Hydrochloride | Alosetron hydrochloride 1 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-036 |