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URSODIOL

ANDA

URSODIOL | A202540 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.6573

per ea

Lowest NADAC/Unit

$0.4350

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49884041301URSODIOL 500 MG TABLET	$0.6573	EA	Generic	—	2026-06-17
00904689004URSODIOL 250 MG TABLET	$0.4350	EA	Generic	—	2026-06-17
49884041201URSODIOL 250 MG TABLET	$0.4350	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 | 1 NDC (1 FSS)

Lowest Price

$78.83

Highest Price

$78.83

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0931-01URSODIOL 500MG TAB	$78.83	FSS	AvKare, LLC	06/14/2028

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

API Supply Chain13 active DMFs2 inactive

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

ICE SPAURSODIOL

DMF 168032003

DAEWOONG BIO INCURSODIOL USP (PROCESS I)

DMF 255362011

DAEWOONG BIO INCURSODIOL USP (PROCESS IV)

DMF 289942015

ALIVUS LIFE SCIENCES LTDURSODIOL USP

DMF 319872017

ARCH PHARMALABS LTDURSODIOL USP

DMF 334102018

ZHONGSHAN BELLING BIOTECHNOLOGY CO LTDURSODIOL

DMF 349372020

MACLEODS PHARMACEUTICALS LTDURSODIOL USP

DMF 393462024

SICHUAN ELIXIR PHARMACEUTICAL CO LTDURSODIOL

DMF 396472024

SYMBIO GENERRICS INDIA PRIVATE LTDURSODIOL

DMF 405482025

PHARMAZELL GMBHURSODIOL

DMF 406262024

SICHUAN XIELI PHARMACEUTICAL CO LTDURSODIOL

DMF 416172025

SHILPA PHARMA LIFESCIENCES LTDURSODIOL USP

DMF 420552025

SHILPA PHARMA LIFESCIENCES LTDURSODIOL USP (BOVINE ORIGIN)

DMF 435242026

AXCAN PHARMA INCInactiveURSODIOL SUSPENSION, 250 MG/ML

DMF 177172004

DAEWOONG BIO INCInactiveURSODIOL USP (URSODEOXYCHOLIC ACID)

DMF 214342008

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

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 14, 2013

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 14, 2013