Last updated: May 31, 2026
MIDAZOLAM IN 0.9% SODIUM CHLORIDE Suppliers: Who Manufactures the Infusion Solution?
Midazolam in 0.9% sodium chloride (often marketed as an infusion/IV premix) is supplied by a small set of branded and generic sterile-injectable manufacturers in the US and Europe. The specific “supplier” depends on the label strength (for example, mg/mL), container/format (bag vs. syringe vs. vial), and whether the product is a hospital-use premix or a pharmacist-compounded admixture.
Execution-critical point: In practice, procurement teams should treat this as a sterile IV premix procurement category and source from manufacturers that are currently shipping an FDA-approved NDC product (or a locally authorized sterile equivalent). Without the product’s exact strength and NDC, a definitive supplier list for “MIDAZOLAM IN 0.9% SODIUM CHLORIDE” cannot be completed.
Which companies supply midazolam in 0.9% sodium chloride IV infusion?
This product category is typically sold under one of these supply structures:
- FDA-approved sterile premix (commercial product): A finished dosage form supplied under an NDC by a listed drug manufacturer (brand or authorized generic).
- Licensed generic sterile premix: Same labeled composition and route, with different manufacturers tied to the NDC.
- Compounding supply chain: When hospitals prepare admixtures, procurement may shift from “premix suppliers” to raw midazolam concentrate suppliers plus sterile diluent suppliers and compounding services.
To produce a correct supplier roster, the exact marketed configuration must be pinned to an NDC and label composition that specifies midazolam plus 0.9% sodium chloride in a defined concentration and dosage form.
What naming conventions affect supplier identification?
Procurement searches commonly miss the correct NDC because the label is indexed under variants such as:
- “midazolam in sodium chloride 0.9%”
- “midazolam injection in 0.9% sodium chloride”
- “midazolam premix for infusion”
- “midazolam IV infusion solution (0.9% NaCl)”
- packaging-format descriptors that change by vendor (bag size, syringe, or vial)
How do I find the authorized suppliers on the Orange Book?
If the product has an FDA-approved NDA/ANDA, the Orange Book listing is the correct starting point to map:
- Applicant/manufacturer
- Dosage form
- Strength
- Patent listings
- Exclusivity status
In procurement terms: Orange Book provides the authoritative manufacturer/applicant to link to current distribution and contracting.
What does Orange Book typically list for midazolam premixes?
For sterile injectables, Orange Book entries often include:
- NDA or ANDA holder as the “applicant”
- Relevant patent estate (drug substance/formulation, method, and packaging)
- Exclusivity periods (data exclusivity and/or patent exclusivity)
Without the specific NDA/ANDA or NDC, supplier names cannot be asserted reliably.
What generic entry risks exist for midazolam in 0.9% sodium chloride?
For a sterile IV premix, generic entry risk is usually driven by:
- Patent thickets for the specific concentration and container system
- Sterility and manufacturing controls (aseptic processing, fill-finish)
- Regulatory pathway requirements for an equivalent infusion solution
Paragraph IV and settlement impacts
Where there is a Paragraph IV challenge, settlement timing can create:
- Delayed generic launch dates for specific strengths and container formats
- Exclusive distribution periods for certain authorized generics
These risks again depend on the exact FDA product configuration.
Which formulations are protected for midazolam in 0.9% sodium chloride?
Patent protection commonly covers one or more of:
- midazolam salt form and concentration in solution
- stabilizer system and pH window (if present)
- infusion container compatibility (extractables/leachables)
- method-of-manufacture for sterile fill-finish
Container and strength matter
Even for the same “drug in diluent” concept, manufacturers can vary by:
- bag vs. syringe vs. vial
- total volume
- labeled mg/mL
- overwrap and storage conditions
Procurement should align to the exact label strength and container format to avoid sourcing errors.
What manufacturing/IP barriers limit additional suppliers?
Sterile premix supply for midazolam in sodium chloride often faces barriers tied to:
- validated aseptic filling lines for the specific container type
- compatibility validation with midazolam and the specific saline diluent
- stability and shelf-life testing for the labeled concentration and storage temperature
- regulatory facility readiness and inspection history
These are frequently the practical reasons the supplier base stays narrow.
How does midazolam in 0.9% sodium chloride compare with midazolam in dextrose or other diluents?
Supply often fragments by diluent. Midazolam can be found as:
- premix saline formulations (0.9% NaCl)
- premix dextrose formulations (commonly D5W or equivalent)
- concentrate-only midazolam that is diluted downstream by hospitals/pharmacies
From a sourcing standpoint:
- a “midazolam in D5W” supplier cannot be substituted for a “midazolam in 0.9% NaCl” product without explicit clinical and labeling compatibility confirmation and correct NDC equivalence.
Commercial sourcing: who can reliably supply hospital inventory?
Reliable supply is usually tied to:
- long-term contract manufacturers with sterile fill-finish capacity
- distributors that can maintain cold-chain requirements if applicable (varies by label)
- ability to support multiple package sizes
For sterile injectables, the usable supplier list should be built from:
- NDC-linked manufacturers
- distributor availability (McKesson/Cardinal/AmeriSource-style channels in the US, and local equivalents in Europe)
- current market presence for each strength and container size
Key Takeaways
- “Midazolam in 0.9% sodium chloride” is a sterile IV premix procurement category whose suppliers depend on the exact labeled concentration, container, and NDC.
- Supplier identification should be anchored to the Orange Book/label-linked NDA/ANDA for the specific configuration.
- Generic entry and additional supplier expansion are constrained by sterile manufacturing, container compatibility, and the patent estate tied to the specific strength/formulation.
FAQs
- How do I map “midazolam in sodium chloride 0.9%” to the correct NDC for supplier sourcing?
- What differences in container format (bag vs syringe) change the supplier and substitution eligibility?
- Do the patent expirations differ by strength for midazolam 0.9% sodium chloride premixes?
- How do hospital compounding and sterile dilution practices affect procurement of “premix” vs “concentrate”?
- Which distributor channels typically carry FDA-approved midazolam 0.9% sodium chloride products?
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
