Last updated: June 3, 2026
BREVIBLOC IN PLASTIC CONTAINER Suppliers: Who Manufactures and Supplies the Active Product and Finished Drug?
Executive summary
Brevybloc in plastic container is the U.S.-market branded formulation of esmolol hydrochloride for intravenous use. The key “supplier” question in pharma terms breaks into two layers: (1) who supplies the drug substance (esmolol hydrochloride) and (2) who supplies the finished-dose product in the plastic container (manufacturing, fill-finish, label/pack). Without the specific FDA NDC(s) and the market authorization (ANDA/NDA holder) and manufacturer-of-record names, a complete, accurate supplier list cannot be produced.
What companies supply Brevibloc (esmolol hydrochloride) in plastic containers in the US market?
Answer (data needed to be complete): A definitive supplier list requires mapping the product’s NDC(s) to the FDA label “Manufactured for/Distributed by” and “Manufactured by” sections, which identify the manufacturer(s) tied to that specific container/pack configuration.
Where supplier identities are published
For branded injectables like Brevibloc, supplier-of-record typically appears in:
- The FDA label (US prescribing information): “Manufactured for/Distributed by” and sometimes “Manufactured by.”
- The FDA Orange Book listing (if applicable) or CDER drug establishment references.
- NDC directory entries that map NDC to labeler and manufacturer.
Which suppliers make esmolol hydrochloride drug substance used for Brevibloc?
Answer (data needed to be complete): Drug-substance suppliers are not consistently listed on the public FDA label for branded injectables, and “supplier” could mean:
- API (esmolol hydrochloride) manufacturer
- API-only distributor
- Contract manufacturing organization for drug substance and/or drug product
A supplier list must be built from:
- FDA facility/API traceability in filings,
- labeled manufacturing statements,
- and (when available) patent or DMF-linked supplier references.
Which manufacturers fill-finish Brevibloc into plastic containers?
Answer (data needed to be complete): Fill-finish for plastic containers depends on:
- container type (for example, single-use premixed plastic),
- batch size and packaging line,
- and whether multiple sites supply the label.
Accurate identification requires:
- the label’s manufacturing site statement for each NDC,
- plus any site-variation noted in the FDA labeling history.
What is the Orange Book status of Brevibloc in plastic container and how does that affect sourcing?
Answer (data needed to be complete): Orange Book status determines whether an approved generic exists that could change manufacturer supply dynamics, but it still does not list all contract suppliers. A complete status answer requires locating the exact active ingredient listing and strength/form on FDA’s Orange Book and matching to the “plastic container” presentation.
What to extract if Orange Book is available for this presentation
- NDA number and reference product
- Dosage form and strength
- Patents listed (drug substance and drug product)
- Exclusivity periods and any granted pediatric exclusivity
Do generic or authorized equivalents change the “supplier” landscape for Brevibloc?
Answer (data needed to be complete): If generics or interchangeable versions exist, supplier competition often shifts to:
- generic labelers and their manufacturers,
- contract fill-finish sites for the same container type.
A full landscape requires:
- listing generic NDCs for esmolol hydrochloride injection and matching them to container format.
What patent estate covers Brevibloc’s plastic container product and does it constrain suppliers?
Answer (data needed to be complete): Patent protection for injectables may cover:
- specific formulation or concentration,
- container-closure interactions,
- methods of manufacture,
- and use/dosing regimens.
But linking the patent estate to “suppliers” requires the exact NDA/presentation mapping and the patent list for that product.
How do NDA labeling “Manufactured for/Manufactured by” statements identify the real suppliers?
Answer (data needed to be complete): The most direct way to identify suppliers is to read the label sections that name:
- manufacturer(s) for the finished product,
- distributor labelers,
- packaging and lot-release sites (when shown).
A supplier list must be anchored to those label statements.
Key takeaways
- “Suppliers for Brevibloc in plastic container” is a two-part problem: API suppliers and finished-dose fill-finish/packaging suppliers.
- A complete, accurate supplier list requires the product’s exact NDC(s or the manufacturer-of-record shown on the FDA label for that specific container configuration.
- Public sources reliably identify the finished-dose manufacturer via label and NDC mappings, while API supplier identities are often not directly disclosed and require filing-linked traceability.
FAQs
- How can I identify the manufacturer-of-record for Brevibloc injection in a specific plastic container using NDC data?
- Are esmolol hydrochloride API suppliers listed on the Brevibloc prescribing information or FDA labels?
- Do container-closure or formulation patents restrict alternative manufacturers for Brevibloc’s plastic container presentation?
- Which FDA pathways (NDA vs ANDA) govern Brevibloc and its generic equivalents for esmolol injection?
- What role do contract fill-finish sites play in the supply chain for IV beta-blockers like esmolol hydrochloride?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. NDC Directory.
- FDA Prescribing Information (Brevibloc, esmolol hydrochloride injection).
