NDC codes

FDA NDC Directory
Product NDC (as listed)70756-701Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70756-0701Add 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
70756-701-30707560701307075607013030 TABLET in 1 BOTTLE (70756-701-30)Marketed from Sep 14, 2020

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
Generic name (nonproprietary)
alosetron
Active ingredients
Alosetron hydrochloride — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Lifestar Pharma LLCNDC labeler code 70756
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213614
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 70756-701_6e1e5a99-5018-42e7-8e2c-bcd0ac1e80fbSPL ID 6e1e5a99-5018-42e7-8e2c-bcd0ac1e80fbSPL set ID 2846a244-7540-442b-81bc-638e641497ceRxCUI 259306, 403975UNII 2F5R1A46YW

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

N470756070130 followed by a unit qualifier and the quantity

Package 70756-0701-30. 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)

About NDC 70756-701

What is NDC 70756-701?
70756-701 is the product NDC for Alosetron, Alosetron hydrochloride 1 mg/1 tablet, listed with the FDA by Lifestar Pharma LLC. 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?
Lifestar Pharma LLC, NDC labeler code 70756. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AlosetronAlosetron hydrochloride .5 mg/1TabletOralBryant Ranch Prepack63629-251763629-2517-01
AlosetronAlosetron hydrochloride 1 mg/1TabletOralBryant Ranch Prepack63629-251863629-2518-01
AlosetronAlosetron hydrochloride .5 mg/1TabletOralLifestar Pharma LLC70756-70270756-0702-30

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
ProductStrengthForm · routeLabelerProduct NDC
AlosetronAlosetron hydrochloride .5 mg/1TabletOralBryant Ranch Prepack63629-2517
AlosetronAlosetron hydrochloride 1 mg/1TabletOralBryant Ranch Prepack63629-2518
AlosetronAlosetron hydrochloride .5 mg/1TabletOralLifestar Pharma LLC70756-702

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