Suppliers and packagers for HYZAAR

HYZAAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387	NDA	Organon LLC	78206-139-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-139-01)	2021-06-01
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387	NDA	Organon LLC	78206-139-02	90 TABLET, FILM COATED in 1 BOTTLE (78206-139-02)	2021-06-01
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387	NDA	Organon LLC	78206-140-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-140-01)	2021-06-01

HYZAAR Suppliers: Who Manufactures Losartan Potassium and Hydrochlorothiazide, and How the Supply Chain Maps to FDA Products

Last updated: May 30, 2026

HYZAAR (losartan potassium 50 mg or 100 mg plus hydrochlorothiazide 12.5 mg or 25 mg) is a branded fixed-dose combination with manufacturing and packaging performed by multiple contract manufacturers across finished-dose and labeler chains. The supplier set is best mapped by (1) FDA NDC labeler/manufacturer listings and (2) Orange Book/ANDA supply chain entities tied to the listed finished dosage forms and strengths.

Because “suppliers” can mean different roles (API vs finished dose vs packaging vs labeler), HYZAAR’s supplier landscape should be interpreted as a network anchored to the FDA labeler (the entity associated with the marketed drug listing) and the cGMP sites that manufacture and package the tablets.

Which companies supply HYZAAR (losartan/hydrochlorothiazide) tablets?

Fast answer: HYZAAR’s supply chain is anchored to the U.S. FDA labeler record for each NDC/strength, with cGMP manufacturing and packaging performed by one or more contract manufacturing organizations and/or internal sites of the NDA holder and its manufacturing partners. The authoritative way to identify the exact “supplier companies” by role and dosage strength is the FDA’s product and labeler records for HYZAAR NDCs, which list the labeler and the manufacturing/packaging site identifiers tied to each listed strength and dosage form.

How to interpret “supplier” for HYZAAR

Common supplier roles in fixed-dose combination generics-branded networks:

• Labeler / NDA holder: the firm responsible for the FDA submission and marketed product listing.
• Finished dose manufacturer: cGMP site that produces the tablet bulk and the final tablet.
• Packaging manufacturer: often a separate cGMP site that packages into bottles/blisters.
• API suppliers: upstream producers of losartan potassium and hydrochlorothiazide active ingredients, typically disclosed indirectly through DMFs and supply contracts rather than always showing on the labeler record.

What HYZAAR’s supplier mapping depends on

• Strength-specific NDCs: HYZAAR comes in multiple strengths (50/12.5, 50/25, 100/12.5, 100/25). Each strength can have different NDCs and potentially different labeler/manufacturer site combinations.
• Package configurations: 30-count vs 90-count bottles can map to different packaging sites.
• Re-assignments over time: contract manufacturing changes can occur without changing the brand name.

How do I find HYZAAR suppliers using the FDA labeler and NDC listings?

Fast answer: Use FDA “Drugs@FDA” product pages for HYZAAR plus the associated NDC directory records to extract labeler and manufacturer/packager names and sites per NDC and strength.

NDC-level fields that identify suppliers

For each HYZAAR NDC/strength, FDA listings typically provide:

• Labeler name
• Manufacturer name
• Packaging/manufacturing site addresses
• Product type (tablet), dosage form, and active ingredient ratio

Why this matters for sourcing and risk

• Finished-dose manufacturing and packaging are the operational choke points for availability.
• API supply risk for losartan potassium or hydrochlorothiazide shows up downstream as batch shortages or manufacturing capacity constraints, but API supplier names are often less visible than labeler/finished-dose site names.

Do patents or exclusivity change HYZAAR suppliers?

Fast answer: Patent/exclusivity status affects the competitive landscape for generics and AB-rated substitutes, not the day-to-day manufacturing assignment for the marketed brand. HYZAAR suppliers primarily change due to manufacturing capacity, contract strategy, and packaging capacity, rather than due to Orange Book exclusivity.

Orange Book relevance

• Orange Book listings identify patent estates tied to NDA approval.
• The patents do not directly list “suppliers,” but the NDA holder’s manufacturing and technology transfer footprint often determines who can produce the authorized brand supply.

Regulatory relevance

• FDA cGMP compliance, site approvals, and changes under SUPAC drive which manufacturers can make the tablets.

Who supplies losartan potassium and hydrochlorothiazide (APIs) for HYZAAR?

Fast answer: The upstream API supplier set is typically disclosed through:

• DMF holders for losartan potassium and hydrochlorothiazide, and
• API manufacturer information embedded in FDA submissions tied to the finished-dose NDA/ANDA supply chain.

Because API suppliers are not always consistently exposed in publicly visible labeler records, the most defensible approach to identify API supplier entities is via DMF-linked information and associated FDA filing references tied to HYZAAR and its generics.

API supply chain structure for fixed-dose combos

• Losartan potassium is an ARB active ingredient with established global supply.
• Hydrochlorothiazide is a widely sourced diuretic API.
• Fixed-dose combination supply requires compatibility of particle properties, tablet blend performance, and stability under the finished-dose formulation.

Which manufacturer sites produce HYZAAR tablets in the US?

Fast answer: HYZAAR’s tablet manufacturing and packaging sites must be identified by the FDA listing for each NDC. The same NDA brand can have multiple production or packaging sites.

What to extract for procurement or due diligence

For each HYZAAR NDC and strength:

• Manufacturer cGMP site (name and address)
• Packaging site (if different)
• Dosage form and strength
• Market status (currently marketed listing vs discontinued)
• Product labeling configuration (bottled vs unit dose)

How does HYZAAR supplier coverage compare with generic losartan/HCTZ tablets?

Fast answer: Generic manufacturers typically have separate ANDA supply chains but must meet bioequivalence and chemistry manufacturing controls. Supplier overlap with HYZAAR is common at the API level and less common at the finished-dose packaging/manufacturing site level.

Procurement implication

• If your goal is continuity of supply at scale, generic sourcing can diversify risk.
• If your goal is brand continuity, rely on HYZAAR NDC-specific manufacturer site mapping.

What generic entry risks exist that could disrupt HYZAAR sourcing?

Fast answer: Generic entry itself does not stop brand manufacturing, but it can change procurement economics, contract terms, and availability of APIs and excipients if the supply base is capacity constrained.

Typical disruption channels

• API capacity reallocation to high-volume generic launches
• Excipient shortages affecting fixed-dose combination production
• Packaging bottle/label supply variability tied to packaging site operations

Key Takeaways

• HYZAAR “suppliers” are best identified from FDA NDC labeler and manufacturer/packager listings per strength and package configuration, since manufacturing and packaging can differ by NDC.
• API suppliers for losartan potassium and hydrochlorothiazide are usually not fully exposed in labeler records and are better mapped via DMF-linked FDA submission history.
• Patent/exclusivity status influences competition, not the immediate manufacturer assignment for the marketed brand tablets.
• For sourcing continuity, supplier mapping must be NDC-specific and strength-specific.

FAQs

1. What does the FDA labeler field mean for HYZAAR sourcing? It identifies the firm responsible for the marketed product listing tied to the NDC, which may differ from the cGMP manufacturing site.
2. Can HYZAAR have multiple manufacturers for the same strength? Yes. Different NDCs and package configurations can map to different manufacturing and packaging sites.
3. How do I identify HYZAAR’s packaging supplier separately from the tablet manufacturer? Use the NDC listing fields that specify packaging and manufacturing site names, which can be different entities.
4. Where do API supplier names for losartan potassium and hydrochlorothiazide appear? Often in DMF-linked information and in references within FDA submissions rather than in the basic labeler NDC directory.
5. Do generic approvals change HYZAAR’s manufacturing suppliers? Typically no, but market shifts can affect upstream API and excipient allocation that can impact availability and lead times.

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References (APA)

1. FDA. Drugs@FDA: HYZAAR product information and labeler/manufacturer references. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (HYZAAR listings and related patents). https://www.accessdata.fda.gov/scripts/cder/ob/