Last updated: May 30, 2026
ISOVUE-300 suppliers: who manufactures, supplies, and distributes iopamidol contrast media (Rx)
ISOVUE-300 (iopamidol 61% w/v, injectable radiographic contrast) is sourced through brands and distributors tied to the manufacturer’s labeler and FDA distribution network. The product’s supplier set in practice is (1) the FDA labeler/manufacturer of record for ISOVUE-300 iopamidol injection and (2) secondary distributors/wholesalers that supply hospitals, imaging centers, and group purchasing organizations (GPOs).
Who manufactures ISOVUE-300 iopamidol injection in the US?
ISOVUE-300’s primary supplier is the company listed as the “Applicant” (and/or “Manufacturer” depending on listing) for the product under the FDA National Drug Code (NDC) labeler entry for ISOVUE-300 iopamidol injection.
What is the active ingredient and strength?
- Drug: iopamidol (iodinated, water-soluble radiographic contrast medium)
- Concentration: 300 mg I/mL (commonly expressed as 61% iopamidol, depending on labeling conventions)
- Dosage form: sterile injectable solution for radiographic imaging
Which labelers should be checked to identify the true manufacturer?
To identify the manufacturing supplier tied to ISOVUE-300, the supplier list must be pulled from:
- FDA NDC Directory entry for ISOVUE-300 (iopamidol injection)
- The drug’s “Labeler” field (labeler is typically the firm responsible for placing the drug on the market)
- The “Applicant” field for the corresponding drug listing (where shown)
What distributors supply ISOVUE-300 to hospitals and imaging centers?
Hospital supply chains generally source ISOVUE-300 through:
- National wholesalers (primary distribution layer)
- GPO channels (contracted supply agreements)
- Contract pharma logistics providers (where state or system purchasing rules require)
How to map distribution suppliers to ISOVUE-300 NDCs
Because distributor availability is NDC specific, supplier identification should be NDC-linked:
- Each NDC can roll up to different packaging configurations and may be distributed through different wholesalers.
- Bulk shortage events often cause substitution across NDCs and product configurations.
How many NDC labelers are used for ISOVUE-300, and does that change suppliers?
Supplier coverage can vary by:
- Container size (e.g., vial volume options)
- Package configuration (unit-of-use vs multi-pack)
- NDC changes after relabeling, contract manufacturing shifts, or packaging relaunches
What counts as a “supplier” for procurement and compliance?
For procurement and regulatory traceability, count two tiers:
- Manufacturing labeler/applicant (accountable supply source)
- Wholesale distributor (delivery and inventory source)
Which procurement channels carry ISOVUE-300 (GPO, IDN, and hospital pharmacy contracts)?
ISOVUE-300 is typically stocked through:
- Large IDNs and hospital pharmacy distributors
- GPO contracts covering contrast media classes
- Imaging department purchasing agreements tied to standard-of-care contrast products
What procurement terms determine which “supplier” dominates?
- Contract price and rebate structure
- Supply continuity clauses
- Allowed substitutions across iopamidol NDCs and equivalent contrast media
- Cold-chain or handling requirements (generally minimal for iopamidol compared with biologics)
Does ISOVUE-300 have multiple manufacturing sites or contract manufacturers?
If present in FDA listing records, multiple manufacturing sites may appear under:
- “Manufacturing” firms associated with the NDC
- Supplement changes in labeling tied to manufacturing transfer
- Packaging and labeling contractors
How to determine whether contract manufacturing changed the supplier
Look for shifts in:
- Manufacturer/labeler firm names tied to the NDC over time
- Manufacturing site addresses linked to the same strength and dosage form
When does ISOVUE-300 supplier availability change due to shortages or relabeling?
Supplier availability can change when:
- FDA identifies shortage status for iodinated contrast products
- Packaging relaunches occur (NDC updates)
- Manufacturing transfers cause temporary lead-time changes
How to link shortage notices to supplier changes
Use shortage events tied to:
- The specific NDC or the active ingredient/class
- The “product” designation in shortage communications
What are the regulatory and listing checkpoints that define “supplier of record” for ISOVUE-300?
For compliance and auditability, the supplier of record is anchored to:
- FDA NDC Directory listing for ISOVUE-300
- Any changes in applicant/labeler information over the product lifecycle
- Any PSUR or postmarketing commitments if tracked by labeler
Orange Book relevance for ISOVUE-300
ISOVUE-300 is not an FDA “Orange Book” small-molecule exclusivity case in the same way as many NDAs with listed patents; iodinated contrast agents are generally covered by the traditional drug listing and compendial/labeling records. Supplier verification still relies on NDC labeling and FDA listing records.
How does ISOVUE-300 compare with alternative iopamidol suppliers and generic risks?
In procurement, “supplier risk” is often about supply continuity and substitution rather than patent exclusivity.
What drives generic or equivalent substitution risk
- Same active ingredient: iopamidol
- Same strength and dosage form
- Equivalent volume and delivery system
- NDC interchangeability by pharmacy purchasing rules
What US companies are most likely to show up as ISOVUE-300 suppliers in supply chains?
In practice, the market typically includes:
- The branded manufacturer/labeler firm for ISOVUE-300 iopamidol injection
- Major national distributors that warehouse and ship sterile injectables
Supplier list format used for procurement
- Manufacturer/labeler (FDA NDC Directory “labeler” firm)
- Wholesale distributor (GPO/wholesaler that delivers to the ordering facility)
- Contract packaging or manufacturing site contractor (if separately listed in FDA records)
Key supplier intelligence for ISOVUE-300 procurement
- Treat “supplier” as two-tier: manufacturing labeler plus delivery distributor.
- Always bind supplier identity to the specific ISOVUE-300 NDC and packaging configuration.
- Monitor shortage and relabeling events for NDC changes that shift the supplier of record.
Key Takeaways
- ISOVUE-300’s supplier set should be defined from FDA NDC Directory labeler/manufacturer entries and then mapped to wholesalers that distribute the same NDC to your channel.
- Supplier identity can shift with NDC updates driven by packaging changes or manufacturing transfers.
- Procurement substitution risk for iopamidol products is generally operational (availability, NDC interchange rules) rather than driven by Orange Book-style exclusivity.
FAQs
1) How do I find the exact ISOVUE-300 manufacturing supplier for my NDC?
Use the FDA NDC Directory entry for the specific ISOVUE-300 NDC and read the labeler/manufacturer fields tied to that NDC.
2) Are ISOVUE-300 distributors different across hospital systems?
Yes. Contracting through GPOs and wholesalers can vary by IDN, state, and contract price bands, and these differences are NDC-specific.
3) What information matters most when auditing ISOVUE-300 supply source?
The NDC labeler/manufacturer of record and the lot traceability chain from receipt back to that labeler.
4) Can ISOVUE-300 availability change without the active ingredient changing?
Yes. Packaging relaunches, NDC updates, and manufacturing site transfers can change lead times and the practical supplier mix even if the active ingredient is constant.
5) Do ISOVUE-300 supplier changes impact clinical substitution decisions?
Clinically, substitution depends on concentration, formulation, and imaging protocol. Operationally, supplier changes often affect whether substitution is permitted under contracting and formulary rules.
References
- FDA. NDC Directory (ISOVUE-300 / iopamidol injection). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ndc/
