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Suppliers and packagers for DEXTROSE 30% IN PLASTIC CONTAINER
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DEXTROSE 30% IN PLASTIC CONTAINER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Icu Medcl | DEXTROSE 30% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 019345 | NDA | ICU Medical Inc. | 0990-8004-15 | 12 POUCH in 1 CASE (0990-8004-15) / 1 BAG in 1 POUCH / 500 mL in 1 BAG | 2019-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for DEXTROSE 30% IN PLASTIC CONTAINER
DEXTROSE 30% IN PLASTIC CONTAINER: Who supplies it and how to qualify vendors
Executive summary: Dextrose 30% injection is supplied by multiple FDA-registered manufacturers under various NDCs, delivered in plastic containers (commonly Viaflex-style bags or equivalent PVC-free/PL bags depending on supplier and site). The supplier landscape for “dextrose 30% in plastic container” is determined primarily by (1) which NDC(s) match the exact container presentation, (2) whether the product is sourced as sterile solution (not a compounding component), and (3) how contracts route through wholesalers and GPOs. Vendor qualification should be anchored to the exact NDC listing and the manufacturer’s facility compliance history, not to “dextrose 30%” generics as a category.
Which companies supply dextrose 30% injection in plastic containers (NDC-level)?
Featured snippet answer: Supplier identification for dextrose 30% in plastic containers is NDC-specific. The practical way to build an approved vendor list is to map each target NDC to its listed manufacturer on the FDA “Orange Book” (if listed) and/or the Drug Registration and Listing System (Drugs@FDA), then verify the plastic container presentation (bag type) from the product labeling and wholesaler item masters.
What to look for in product naming to avoid mismatches
Search strings that typically map to the same strength but different container presentations:
- “Dextrose Injection, USP 30%”
- “Dextrose 30% in Plastic Container”
- “Dextrose Injection, USP 30% (bag)”
- “Dextrose 30% w/v”
Common non-equivalences that change supplier sourcing: - Container type: plastic bag vs. glass; PVC-free vs. PVC
- Fill size: single bag volume (e.g., 250 mL, 500 mL, 1000 mL) vs. other configurations
- Rx vs. hospital bulk pack presentations in wholesaler catalogs
- Sterility assurance method and container material changes across manufacturing sites
What is the Orange Book status of dextrose 30% in plastic containers?
Dextrose injection is typically treated as a commodity sterile solution rather than a drug with a meaningful, patent-constrained branded exclusivity regime. For vendor sourcing, the Orange Book is usually not the primary driver of supply eligibility. Regulatory control instead hinges on:
- FDA listing and labeling status under Drugs@FDA
- Current Good Manufacturing Practice (cGMP) compliance at the manufacturing site(s)
- Container closure system and sterility claims in labeling
How do suppliers for dextrose 30% in plastic containers differ by manufacturer vs. wholesaler?
Featured snippet answer: Manufacturers produce the sterile drug product and container system; wholesalers/GPOs distribute via their catalog and contract channels. A “supplier” in procurement terms may be a wholesaler (contracted distributor) even when the manufacturing supplier is different.
Procurement taxonomy
- Manufacturing supplier (drug product/sterile solution): FDA-registered manufacturer(s) associated with specific NDCs.
- Distribution supplier (procurement channel): Cardinal Health, McKesson, AmerisourceBergen, or regional equivalents depending on contracts and GPO agreements.
- Repackagers/secondary packers (less common for finished 30% injection): Some distributors repackage cartons, but the finished container labeling generally remains manufacturer-controlled.
Which product presentations count as “plastic container” for dextrose 30%?
Featured snippet answer: “Plastic container” generally means sterile solutions supplied in a preformed plastic bag (commonly flexible polymer bag systems used for IV infusions), with a specified container volume and a defined secondary packaging format.
Container system attributes that affect procurement equivalence
- Bag size (mL)
- Bag material (PVC-free vs. PVC) and any listed product-specific compatibility statements
- Port configuration (e.g., injection site size and closure)
- Overwrap type and shipping carton configuration
How do you confirm the correct supplier for a dextrose 30% plastic-container item in inventory systems?
Featured snippet answer: Match on NDC plus container volume, then confirm lot-level manufacturer and expiration on the carton and inner bag labels.
Operational checks that prevent wrong-supplier sourcing
- NDC in your item master matches the expected strength and volume
- Labeling indicates “Dextrose Injection, USP 30%” (or equivalent)
- Manufacturer name and address on the carton match your approved manufacturer list
- Container material statement aligns with your hospital compatibility requirements
What generic entry risks exist for dextrose 30% injection?
Featured snippet answer: For dextrose 30% injection, supply risk is less about IP barriers and more about manufacturing capacity, sterilization system availability, container supply, and FDA quality outcomes.
Primary supply risks
- Sterile manufacturing capacity constraints
- Supply variability for the plastic container system
- Quality events or voluntary recalls that remove specific lots or NDCs from distribution
- Site shutdowns or import disruptions
Who are the most common manufacturers of sterile dextrose injection products used in hospitals?
Featured snippet answer: Multiple manufacturers supply dextrose injection strengths. In practice, the “most common” depends on the NDC(s) your health system uses, and the final selection is driven by GPO contracts and distributor on-contract availability.
How to build the actual ranked list
To generate a defensible vendor list (manufacturing suppliers), procurement teams should:
- Pull the exact NDC(s) used clinically
- Identify the firm(s) associated with those NDCs on FDA labeling
- Validate container presentation in the prescribing information or FDA label
- Cross-check manufacturing site cGMP standing via FDA inspection history and enforcement outcomes (if available)
How does dextrose 30% in plastic containers compare with dextrose 10% and 50% supply?
Featured snippet answer: The supply base for different dextrose strengths often overlaps at the manufacturing and container-systems level, but availability can diverge because of fill-line configuration, bag size demand, and contract mixing strategies.
Why strength changes supplier availability
- Different concentration solutions can require different processing parameters
- Different bag sizes and fill volumes change demand allocation
- Contracting for higher-use strengths (commonly 5% and 10%) may consume production capacity
What does FDA regulatory status mean for sourcing dextrose 30% in plastic containers?
Featured snippet answer: Regulatory status for procurement is driven by whether the product is listed, labeled correctly, and manufactured in compliance with cGMP.
Key compliance signals procurement should verify
- Current FDA listing and label availability for the exact NDC
- Recalls and market withdrawals for specific lot numbers (not just the product name)
- Current manufacturing site status and any enforcement actions tied to that product’s manufacturing processes
Key Takeaways
- Supplier identification for “DEXTROSE 30% IN PLASTIC CONTAINER” is NDC-specific and presentation-specific.
- The highest-confidence approach is NDC-to-manufacturer mapping using FDA label data, then verifying lot-level manufacturer and container type in procurement receiving.
- Supply risk for dextrose 30% is usually driven by manufacturing capacity, container-system supply, and quality events rather than IP or exclusivity barriers.
FAQs
1) Is “dextrose 30% injection” the same as “dextrose 30% w/v”?
In most cases the strength equivalence holds, but procurement equivalence still requires matching NDC, bag size, and labeling.
2) Can a distributor sell dextrose 30% in plastic containers from multiple manufacturers?
Yes. Wholesalers often carry multiple NDCs/brandings that correspond to different manufacturing firms.
3) How do I ensure the container is PVC-free when ordering dextrose 30%?
Confirm the container system statement on the labeling and match the exact NDC and item master entry used by your formulary.
4) Do patent challenges affect sourcing for dextrose 30% injection?
Typically not in the way that patented small-molecule drugs do; sourcing constraints are usually manufacturing and regulatory-quality driven.
5) What is the fastest way to replace a failed supplier line for dextrose 30%?
Replace using an equivalent NDC with the same strength and container presentation, then validate lot labeling at receipt.
References (APA)
No sources were provided in the prompt, and no citations can be generated without verifiable NDC/manufacturer listing documents for “dextrose 30% in plastic container.”
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