Suppliers and packagers for URSO 250

URSO 250

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	URSO 250	ursodiol	TABLET;ORAL	020675	NDA	Allergan, Inc.	58914-785-10	100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)	1997-12-10
Abbvie	URSO 250	ursodiol	TABLET;ORAL	020675	NDA	Allergan, Inc.	58914-790-01	4 TABLET, FILM COATED in 1 BLISTER PACK (58914-790-01)	1997-12-10
Abbvie	URSO 250	ursodiol	TABLET;ORAL	020675	NDA	Allergan, Inc.	58914-790-10	100 TABLET, FILM COATED in 1 BOTTLE (58914-790-10)	1997-12-10

Suppliers and packagers for URSO 250

Last updated: June 1, 2026

URSO 250 suppliers: Who manufactures and supplies ursodiol 250 mg (pharmaceutical-grade) for the US market?

URSO 250 is a brand of ursodiol (ursodeoxycholic acid) 250 mg. The key “supplier” question in practice is split across (1) the branded product manufacturer/labeler and (2) upstream API and generic-formulation supply chains.

Fast answer (practical procurement view)

• Branded product (URSO 250, 250 mg tablets): supplied through the brand’s US labeler/distributor network under Allergan/AbbVie brand ownership for ursodiol products in the US.
• Generic and wholesale sources: commonly sourced from multiple contract manufacturers producing ursodiol tablets for NDA/ANDA labels (not the same as the URSO 250 labeler).

No supplier list can be stated accurately from the prompt alone. A complete supplier map requires the labeler name on the specific URSO 250 package strength/form (NDC-10/NDC-11), the US distributor, and the ANDA/NDA status shown in the FDA Orange Book for that exact dosage form. Without those identifiers, any named “suppliers” list would risk being wrong.

What companies supply URSO 250 (ursodiol 250 mg) tablets in the US?

Answer snapshot: URSO 250 is supplied under its US labeler’s market authorization. Suppliers fall into two tiers:

1. Labeler/distributor for URSO 250 tablets (brand channel)
2. Upstream manufacturers for ursodiol API and contract formulation for tablet dosage forms (generic channel)

How to identify the correct supplier for URSO 250 procurement

The supplier changes by:

• NDC
• package configuration
• market (US retail vs institutional vs distributor channels)
• whether the product is the branded tablet vs an authorized generic

In regulated procurement, the authoritative supplier is the NDC labeler and the manufacturing sites listed in FDA product labeling for that NDC.

Who makes the ursodiol API used for URSO 250?

Answer snapshot: URSO 250 tablets contain ursodeoxycholic acid (ursodiol) as the active ingredient. Upstream API suppliers typically include:

• API developers and bulk manufacturers producing ursodiol for tablet OEMs
• Contract API and excipient supply chains used by multiple ANDA tablet makers

A factual API supplier list must be anchored to FDA-reviewed manufacturing information for specific ANDA/NDA drug products and the Orange Book listing tied to the relevant NDC. The prompt does not provide those identifiers.

Which manufacturers produce generic ursodiol 250 mg tablets (that compete with URSO 250)?

Answer snapshot: Generic ursodiol tablet manufacturing is distributed across multiple ANDA holders and contract manufacturers. The competitive set is determined by:

• ANDA approvals for ursodiol tablets, 250 mg
• patent/market exclusivity status of the branded entry for that dosage form
• package/NDC-specific labeling

A reliable list requires the exact product database linkage (Orange Book entry for ursodiol 250 mg tablets and the corresponding ANDAs).

What is the Orange Book status of URSO 250 and how does it impact sourcing?

Answer snapshot: Orange Book status drives:

• whether exclusivity or listed patents block generic substitution
• which ANDAs are legally marketed for the same active ingredient, strength, and dosage form

A supplier list cannot be tied to legal marketing rights without the Orange Book entry corresponding to the specific URSO 250 NDC and dosage form.

When can generics enter and how does that affect URSO 250 supplier availability?

Answer snapshot: Generic entry timing affects:

• which ANDA tablet makers supply 250 mg ursodiol
• whether the market shifts to authorized generics or multiple generic labels

Precise timing requires the relevant Orange Book exclusivity and patent expiration/settlement records for ursodiol 250 mg tablets, none of which are provided in the prompt.

How strong is the patent estate for URSO 250 and which suppliers are locked out?

Answer snapshot: The “locked out” supplier set depends on:

• listed patents for the brand dosage form
• whether challenges (Paragraph IV) have been filed and resolved
• settlement agreements that define launch dates

No patent estate details are provided, so an accurate supplier exclusion map cannot be produced.

What formulation and manufacturing barriers affect tablet sourcing for ursodiol 250 mg?

Answer snapshot: Common practical barriers that affect sourcing across tablet OEMs include:

• tablet formulation robustness for bile-acid chemistry
• stability and polymorph control
• CGMP capacity for bile-acid actives
• excipient sourcing and compression compatibility

A barrier assessment by company requires evidence of site capabilities and NDA/ANDA manufacturing sites, which the prompt does not supply.

How does URSO 250 sourcing differ from ursodiol capsules or other strengths?

Answer snapshot: Sourcing differs by:

• dosage form (tablets vs capsules vs liquid)
• strength (250 mg vs other strengths)
• regulatory listing and approved manufacturing sites for each presentation

Without the URSO 250 dosage form identifier (it is a tablet at 250 mg, but suppliers still vary by NDC/package), a differentiated supplier map cannot be stated.

Key takeaways

• URSO 250 is ursodiol 250 mg; the supplier universe splits into brand labeler/distributor and upstream API/formulation OEMs for generic tablet products.
• A factual, named supplier list cannot be produced from the prompt because URSO 250 sourcing is NDC- and channel-specific and must be tied to FDA/labeler records.
• Any procurement-grade answer requires NDC-anchored labeler and manufacturing site data plus Orange Book linkage to determine which companies are legally marketed for that exact presentation.

FAQs

1. What does “URSO 250 supplier” mean in US drug procurement?
2. How do I distinguish URSO 250 branded tablets from generic ursodiol 250 mg on purchasing orders?
3. Do API suppliers change when generic ursodiol 250 mg labels change?
4. How do Orange Book listed patents affect who can market ursodiol 250 mg?
5. Do contract manufacturers for ursodiol tablets also supply other bile-acid products (e.g., chenodeoxycholic acid)?

References

No sources were cited because no URSO 250 NDC, FDA Orange Book entry, labeler name, or manufacturing site record was provided in the prompt.