Last updated: April 23, 2026
Who manufactures ZADITOR and where do supplies come from?
ZADITOR is an ophthalmic formulation of ketotifen fumarate (antihistamine/mast-cell stabilizer). The supplier ecosystem is best evidenced by the labeled product holders and registered manufacturers appearing on the FDA’s Orange Book and by the manufacturing/labeling parties shown on product labeling.
Which companies are the “product” and “manufacturer” on record?
The FDA’s Orange Book assigns a labeler (the firm responsible for marketing the listed drug product) and identifies the applicable NDA/ANDAs and strength for the listed product. ZADITOR’s ophthalmic ketotifen fumarate strengths and labeling are associated with specific listed firms on the Orange Book record.
Recorded supply-side identifiers for ZADITOR (ketotifen fumarate ophthalmic)
| Evidence type |
What it tells you |
How it maps to “suppliers” |
| FDA Orange Book listing |
Labeler/holder and listed drug entry |
Identifies the marketing firm that coordinates supply for the marketed product |
| FDA listing of dosage form/strength |
Confirms the exact product configuration |
Prevents supplier mismatch across strengths and dosage forms |
| Labeling/manufacturer text |
Plant-level or firm-level manufacturing statements |
Supports vendor qualification for production |
What are the practical “supplier” categories for ZADITOR?
For procurement, supply due diligence for ZADITOR typically splits into two supplier classes:
-
Labeler/marketing supplier (product holder)
- The company on FDA listing that is accountable for the marketed drug product supply.
-
Manufacturing and repackaging supply chain
- Firms that actually manufacture drug product and/or package it for distribution under the ZADITOR label.
What supplier names are identifiable from the public record in this context?
No complete, citable supplier roster can be produced from the information provided in the prompt alone. The task requires extracting supplier identities from authoritative sources (primarily the FDA Orange Book and ZADITOR labeling records), but the underlying records are not included here.
What can be stated from the record without inventing supplier names?
- ZADITOR is a ketotifen fumarate ophthalmic drug.
- “Suppliers” for this product can be operationally defined as:
- the FDA-listed labeler for the ZADITOR NDC entry, and
- the FDA-listed/manufacturer parties on the same entry or in product labeling.
That is the boundary of what can be stated without citing the missing Orange Book and labeling record details for ZADITOR.
Key Takeaways
- ZADITOR is ketotifen fumarate ophthalmic and has a defined FDA record footprint (Orange Book and labeling).
- “Suppliers” must be pulled from the FDA Orange Book labeler/manufacturer fields and on-package labeling for the exact ZADITOR NDC(s).
- A definitive supplier name list cannot be provided from the prompt content alone without citing those FDA and labeling fields.
FAQs
-
Is ZADITOR a prescription or OTC ophthalmic drug?
It is marketed as an OTC ophthalmic ketotifen fumarate product.
-
Is the supplier list the same across all ZADITOR strengths?
Not necessarily. Different strengths or package configurations can map to different NDCs and sometimes different labeler/manufacturer combinations.
-
What FDA source best identifies the ZADITOR labeler?
The FDA Orange Book listing for the specific ketotifen fumarate ophthalmic NDC entry.
-
How do manufacturers differ from labelers?
The labeler is the FDA marketing firm listed for the product. Manufacturers are the firms performing manufacturing and/or packaging, which can differ.
-
What is the fastest way to validate supply chain candidates?
Match candidates against the Orange Book labeler/manufacturer fields for the exact NDC(s), then confirm against current package labeling.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Search: ketotifen fumarate ophthalmic; ZADITOR NDC entries). https://www.accessdata.fda.gov/scripts/cder/ob/
