Prescription drug · NDA
Lotronex (Alosetron hydrochloride) NDC 83107-013
Alosetron hydrochloride .5 mg/1 · Tablet · Oral · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-013-30 | 8310700133083107001330 | 30 TABLET in 1 BOTTLE (83107-013-30)Marketed from Jan 1, 2026 |
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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Legacy Pharma USA Inc.NDC labeler code 83107
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021107
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 83107-013_4db1d464-27cc-80a9-e063-6394a90ade00SPL ID 4db1d464-27cc-80a9-e063-6394a90ade00SPL set ID c216e967-436f-475a-8e6a-2ad11adc63afRxCUI 259306, 261362, 403975, 540181UNII 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
N483107001330followed by a unit qualifier and the quantityPackage 83107-0013-30. 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)
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.
About NDC 83107-013
- What is NDC 83107-013?
- 83107-013 is the product NDC for Lotronex (alosetron hydrochloride), Alosetron hydrochloride .5 mg/1 tablet, listed with the FDA by Legacy Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lotronex (Alosetron hydrochloride).
- What is the active ingredient?
- Alosetron hydrochloride.
- Who is the labeler?
- Legacy Pharma USA Inc., NDC labeler code 83107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lotronex?
- 3 other product NDCs are listed under this name. See all Lotronex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lotronex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lotronexalosetron hydrochloride | Alosetron hydrochloride 1 mg/1 | TabletOral | Legacy Pharma USA Inc. | 83107-012 | 83107-0012-30 |
| Lotronexalosetron hydrochloride | Alosetron hydrochloride .5 mg/1 | TabletOral | Sebela Pharmaceuticals Inc. | 54766-894 | 54766-0894-03 |
| Lotronexalosetron hydrochloride | Alosetron hydrochloride 1 mg/1 | TabletOral | Sebela Pharmaceuticals Inc. | 54766-895 | 54766-0895-03 |
Other NDCs under NDA 021107
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 |
|---|---|---|---|---|
| Lotronexalosetron hydrochloride | Alosetron hydrochloride .5 mg/1 | TabletOral | Sebela Pharmaceuticals Inc. | 54766-894 |
| Lotronexalosetron hydrochloride | Alosetron hydrochloride 1 mg/1 | TabletOral | Sebela Pharmaceuticals Inc. | 54766-895 |
| Lotronexalosetron hydrochloride | Alosetron hydrochloride 1 mg/1 | TabletOral | Legacy Pharma USA Inc. | 83107-012 |