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URSODIOL

ANDA

URSODIOL | A211301 | AMNEAL PHARMACEUTICALS CO GMBH

1 strength0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.4208

per ea

Lowest NADAC/Unit

$0.4208

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69238154001URSODIOL 300 MG CAPSULE	$0.4208	EA	Generic	—	2026-06-17
50268079715URSODIOL 300 MG CAPSULE	$0.4208	EA	Generic	—	2026-06-17

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

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 (1)

#001 — 300MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 16, 2018

No patent or exclusivity listings for this strength.