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ALOSETRON HYDROCHLORIDE

ANDA

ALOSETRON HYDROCHLORIDE | A213614 | MANKIND PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LOTRONEX(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$3.62

per ea

Lowest NADAC/Unit

$1.95

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70756070130ALOSETRON HCL 1 MG TABLET	$3.62	EA	Generic	—	2026-08-19
70756070230ALOSETRON HCL 0.5 MG TABLET	$1.95	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDALOSETRON HYDROCHLORIDE USP

DMF 221252009

NURAY CHEMICALS PVT LTDALOSETRON HYDROCHLORIDE

DMF 273782013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDALOSETRON HYDROCHLORIDE

DMF 274702013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 8, 2023	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 9, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 9, 2020