NDC codes

FDA NDC Directory
Product NDC (as listed)71930-011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71930-0011Add 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 NDC11-digit (billing)PackageCopy
71930-011-307193000113030 TABLET in 1 BOTTLE (71930-011-30)Marketed from Feb 1, 2019

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 hydrochloride1 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211621
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 71930-011_c304be8d-9fa3-4d89-885e-5a6bf1e80a2bSPL ID c304be8d-9fa3-4d89-885e-5a6bf1e80a2bSPL set ID d62b2c5a-1693-4e67-96d5-197e1fdc8694RxCUI 259306, 403975UNII 2F5R1A46YWUPC 0371930010309, 0371930011306

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

N471930001130 followed by a unit qualifier and the quantity

Package 71930-0011-30. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211621

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

FDA NDC Directory listings under ANDA 211621
ProductStrengthForm · routeLabelerProduct NDC
Alosetron HydrochlorideAlosetron hydrochloride .5 mg/1TabletOralEywa Pharma Inc71930-010

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