Last updated: June 9, 2026
Executive summary
- Dantrium is dantrolene, a prescription skeletal muscle relaxant. Supply is handled by a small set of branded manufacturers and multiple generic labelers under FDA oversight, with product availability shaped by active ingredient sourcing, sterile-free manufacturing constraints, and contract manufacturing capacity.
- This answer cannot be produced because it requires current, product-specific supplier and manufacturing-site identification (brand vs generic, dosage form strength, NDC-level mapping, and up-to-date FDA/EU listings). Without those inputs, any supplier list would risk being materially wrong.
What companies supply Dantrium (dantrolene) in the US?
Featured snippet: Supplier identification for Dantrium requires current NDC-level mapping from FDA resources (e.g., Orange Book, drug listing, and product labeling), plus manufacturing-site verification from labeler and facility records. A reliable, complete supplier list cannot be generated from the provided information.
Which dosage forms change the supplier list?
- Dantrium and dantrolene products exist in more than one dosage form/strength across jurisdictions.
- Supplier attribution often differs by:
- Strength (e.g., 25 mg vs 50 mg).
- Formulation (capsules/tablets vs other solid oral forms).
- Generic vs reference product.
How does labeler vs manufacturer affect “supplier” answers?
- FDA “labeler” can differ from the actual manufacturing site.
- For litigation and contracting, the manufacturing entity matters more than the labeler for:
- API supply chain
- intermediate control
- batch release/testing responsibilities
What is the Orange Book status of Dantrium (dantrolene)?
Featured snippet: Orange Book status is drug-product specific and changes with reformulations, generic entries, and exclusivity transfers. A complete Orange Book status table requires the exact marketed product identifiers (reference product, strengths, and NDCs).
Which patents or exclusivities usually drive supply constraints?
- Patent/exclusivity can delay some generic manufacturing.
- Manufacturing capacity and API availability often dominate when shortages occur, even after exclusivity ends.
How do generic entries typically appear for dantrolene?
- Multiple applicants may be approved over time.
- Each approved application can have different manufacturing sites and different supply reliability.
Which suppliers provide dantrolene API (active pharmaceutical ingredient)?
Featured snippet: API suppliers must be identified via API DMFs, supplier chain disclosure in regulatory submissions, and corroborating manufacturing documentation. No API supplier list can be stated accurately from the prompt alone.
What records identify dantrolene API sources?
- FDA Drug Master File (DMF) listings (for API)
- Information in application/labeling submissions
- Contract manufacturing agreements disclosed indirectly via quality agreements and inspection reports
Why API sourcing matters for Dantrium supply
- Solid oral muscle relaxants still depend on:
- consistent polymorph control
- impurity profile control
- solvent and purification capability
- API shortages drive generic product shortages faster than branded inventory depletion.
What generic Dantrium suppliers exist if the branded product is unavailable?
Featured snippet: Generic supplier identification requires the NDC-to-applicant mapping for “dantrolene” products and the current market availability per strength and dosage form.
How many manufacturers typically compete for dantrolene generics?
- Competition varies by geography and strength.
- The number of manufacturers can change year-to-year with approvals, withdrawals, and quality issues.
What generic entry risks affect supplier selection?
- Recalls, warning letters, and manufacturing deviations can remove a supplier quickly.
- Short shelf-life during distribution can also reduce effective supply.
How does EU supply of dantrolene compare with US suppliers?
Featured snippet: EU supply requires EMA/national agency product registration data, including marketing authorization holders and manufacturing sites per product strength.
What data sources map EU suppliers?
- EU marketing authorization holder (MAH) records
- National product registers for manufacturing sites
- Parallel trade rules that affect “who supplies” a pharmacy shelf
Why the EU supplier set may differ
- The MAH might be different from the manufacturing site.
- Distribution models differ across member states.
What drug shortages affect Dantrium supply, and who fills the gap?
Featured snippet: Shortage fill-in depends on current market-specific inventory and approved manufacturing capacity. A current shortage and substitute supplier plan requires live shortage tracking and NDC-level availability.
What triggers shortage events for dantrolene products?
- API availability
- manufacturing batch failures
- inspection-driven shutdowns
- packaging line disruptions
How wholesalers and distributors influence “who supplies”
- Wholesalers may source from multiple manufacturers.
- Pharmacy “supplier” is often a distributor, not the manufacturer.
Key takeaways
- A factual, actionable supplier list for Dantrium (dantrolene) cannot be produced from the provided prompt.
- Reliable supplier identification requires NDC/product-level mapping and current regulatory and manufacturing-site data.
- Supplier attribution should separate labelers from actual manufacturers and API sources when used for R&D, licensing, contracting, or litigation.
FAQs
- Which NDCs correspond to Dantrium (dantrolene) and how does that change the supplier list?
- How do I map dantrolene generics to their manufacturing sites in the FDA system?
- Which regulatory filings identify dantrolene API sources (DMF-driven mapping)?
- What quality or inspection events most often disrupt dantrolene generic supply?
- How do EU marketing authorization holders for dantrolene differ from the actual manufacturers?
References
- FDA Orange Book. U.S. FDA Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA Drug Shortages. U.S. FDA Drug Shortages database. https://www.accessdata.fda.gov/scripts/drugshortages/
- FDA NDC Directory (Drug Listing). U.S. FDA NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
