Suppliers and packagers for zyloprim

zyloprim

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-883-01	100 TABLET in 1 BOTTLE (16571-883-01)	2023-09-21
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-883-09	90 TABLET in 1 BOTTLE (16571-883-09)	2023-09-21
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-883-10	1000 TABLET in 1 BOTTLE (16571-883-10)	2023-09-21

Suppliers and packagers for zyloprim

Last updated: May 28, 2026

ZYLOPRIM supplier landscape: Who manufactures allopurinol tablets and Zyloprim generics by NDA/ANDA, strength, and geography?

ZYLOPRIM is brand allopurinol (xanthine oxidase inhibitor) marketed for gout and hyperuricemia. Supplier mapping depends on the specific FDA application behind the commercial label (NDA holder for ZYLOPRIM vs. ANDA/authorized generics for equivalents) and the strength (most commonly 100 mg and 300 mg tablets).

No dataset was provided that ties ZYLOPRIM to a specific FDA labeler/NDC, ANDA number, or current FDA-listed manufacturer for the exact products in scope. With that missing, a complete and accurate “suppliers” answer (who makes the product, which sites, and which FDA applications) cannot be produced.

What companies supply ZYLOPRIM (allopurinol) tablets in the US market?

Featured-snippet answer: ZYLOPRIM is supplied through the brand’s labeled manufacturer/labeler and, for equivalents, by ANDA manufacturers listed under the corresponding NDCs on FDA product labeling and the Orange Book.

To produce a supplier list, this requires at minimum: the NDC(s) in scope for “ZYLOPRIM,” the FDA labeler, and the listed manufacturing sites and application numbers.

Which strength formats drive different supplier listings (100 mg vs 300 mg tablets)?

Tablet strengths frequently map to different NDCs and sometimes different manufacturing sites. Without NDC-by-strength mapping, any supplier list risks mixing sites or companies across strengths.

Does “supplier” mean labeler, manufacturer, or API producer for allopurinol?

• Labeler: the firm shown on the package label.
• Manufacturer: site that fills/tests the finished dose.
• API supplier: allopurinol source used by the finished-dose manufacturer. These layers usually have different company names. A defensible supplier answer requires stating which layer is requested.

Which FDA applications back ZYLOPRIM and its equivalents (NDA vs ANDA vs authorized generic)?

Featured-snippet answer: ZYLOPRIM maps to a specific NDA for brand allopurinol, while most competing products are ANDAs or authorized generics tied to that active ingredient.

A supplier-to-company mapping requires the application numbers and the Orange Book “Applicant” and “Manufacturer” fields for the specific listed strengths.

How to identify the correct supplier using Orange Book labeler data

A complete supplier answer must pull:

• Orange Book application number for the exact strength
• Applicant/holder
• Patents listed (for market lock and challenge context, if relevant)
• Listed “Dosage Form” and “Route”
• For many products: associated manufacturing info from labeling or drug listing

What patent and exclusivity status affects who can supply ZYLOPRIM equivalents?

Featured-snippet answer: Allopurinol is an older small molecule and is typically off primary regulatory exclusivity, so supply competition usually depends more on manufacturing readiness and ANDA status than on brand exclusivity.

A patent-driven supplier list still requires the specific Orange Book listing for ZYLOPRIM and any listed exclusivities for the reference product.

Does ZYLOPRIM face Paragraph IV challenges that change supplier availability?

Paragraph IV events can redirect market supply to challengers post-settlement or after a court outcome. This requires specific litigation and settlement documentation tied to the FDA listing, which is not present.

What generic entry risks exist for ZYLOPRIM (and how do suppliers mitigate them)?

Featured-snippet answer: For older small-molecule tablets, the main entry barriers are manufacturing controls, BE/CMC compliance, and facility inspection outcomes, not complex regulatory exclusivity.

A supplier-focused risk mapping needs:

• The ANDA list for each strength
• Current approvals and any FDA holds
• Facility inspection records by manufacturer site

None of this can be derived without the FDA/NDC/ANDA anchors.

How does ZYLOPRIM compare with common allopurinol competitors in terms of supplier diversity?

Featured-snippet answer: Allopurinol typically has multiple suppliers due to broad ANDA competition, with supplier diversity varying by strength and by NDC.

A correct comparison requires NDC- and labeler-level granularity across brands/generics, which is not included in the input.

Which jurisdictions control manufacturing approvals for ZYLOPRIM supply?

Featured-snippet answer: In the US, supply is controlled by FDA approval status (NDA/ANDA), labeler responsibility, and manufacturing site compliance. In other jurisdictions, national regulatory frameworks (EMA for EU, MHRA for UK, etc.) govern marketing authorization.

A jurisdiction-by-jurisdiction supplier table requires regulatory listing data by country.

What formulation or manufacturing patents protect ZYLOPRIM supply chains?

Featured-snippet answer: For tablets of allopurinol, protection often centers on active ingredient claims and older patent estates; formulation and process patents can exist for specific dose forms or manufacturing methods.

A protected-supply-chain answer requires the exact ZYLOPRIM patent portfolio from the Orange Book (and any continuation family members), which is not supplied.

What does the Orange Book status of ZYLOPRIM show about current supply constraints?

Featured-snippet answer: The Orange Book lists ZYLOPRIM’s NDA entry, patents, and any exclusivities. Supply constraints persist only while relevant patents block approval (or trigger litigation/authorized manufacturing arrangements).

Producing the Orange Book “status” summary requires the Orange Book entry and its listed patents for the exact reference product/strength.

What key takeaways matter for identifying ZYLOPRIM suppliers?

1. “Supplier” must be defined at labeler vs finished-dose manufacturer vs API supplier level.
2. Supplier mapping depends on the exact ZYLOPRIM strength and NDC, because different strengths and NDCs can map to different manufacturing sites.
3. A defensible supplier list requires FDA anchors (NDA/ANDA number and Orange Book or FDA drug listing fields) tied to the ZYLOPRIM product label being analyzed.

FAQs

1. Who is the labeler for ZYLOPRIM allopurinol tablets in the US?
2. Which manufacturers produce ZYLOPRIM 100 mg vs ZYLOPRIM 300 mg tablets?
3. What NDA number is the FDA reference for ZYLOPRIM allopurinol tablets?
4. Which ANDA holders compete with ZYLOPRIM for allopurinol tablets and how many per strength?
5. Do ZYLOPRIM’s listed Orange Book patents still restrict generic supply for any strengths?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ .