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ALOSETRON HYDROCHLORIDE

ANDA

ALOSETRON HYDROCHLORIDE | A211621 | HIBROW HEALTHCARE PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LOTRONEX(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$3.92

per ea

Lowest NADAC/Unit

$2.05

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
71930001130ALOSETRON HCL 1 MG TABLET	$3.92	EA	Generic	—	2026-06-17
71930001030ALOSETRON HCL 0.5 MG TABLET	$2.05	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$100.00

Highest Price

$200.00

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71930-0010-30ALOSETRON HCL 0.5MG TAB	$100.00	FSS	Golden State Medical Supply, Inc.	06/14/2028
71930-0011-30ALOSETRON HCL 1MG TAB	$200.00	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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 -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 16, 2019

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 16, 2019