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Suppliers and packagers for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
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HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% 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 |
|---|---|---|---|---|---|---|---|---|---|
| B Braun | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 019952 | NDA | B. Braun Medical Inc. | 0264-9567-10 | 24 CONTAINER in 1 CASE (0264-9567-10) / 500 mL in 1 CONTAINER | 1992-07-20 |
| B Braun | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 019952 | NDA | B. Braun Medical Inc. | 0264-9577-10 | 24 CONTAINER in 1 CASE (0264-9577-10) / 500 mL in 1 CONTAINER | 1992-07-20 |
| B Braun | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 019952 | NDA | B. Braun Medical Inc. | 0264-9587-20 | 24 CONTAINER in 1 CASE (0264-9587-20) / 250 mL in 1 CONTAINER | 1992-07-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER: Key Suppliers, Sourcing Map, and Procurement Risks
Heparin sodium 20,000 units in Dextrose 5% (D5W) packaged in plastic containers is a sterile, compounded IV product commonly supplied through branded sterile manufacturers and large hospital-compounding suppliers; the exact “20,000 units/XX mL in D5W plastic container” configuration is typically reflected on the label by the concentration, total volume, and container type. Supplier selection depends on (1) whether the product is an FDA-approved packaged drug, (2) whether it is a distributed hospital-use stock product, and (3) whether procurement is through contract sterilization or outsourcing facilities.
Because “heparin sodium in dextrose 5% in plastic container” is a combination of an anticoagulant plus the IV diluent and container format, the supplier universe is narrower than for plain heparin and is usually tied to specific label presentations.
What manufacturers supply “Heparin Sodium 20,000 Units in Dextrose 5%” in plastic containers?
Answer: Suppliers are generally the companies that produce sterile heparin sodium IV admixture presentations and the distributors/wholesalers that carry those NDC-labeled presentations for hospital procurement. The “plastic container” wording points to a bag or minibag (PVC-free/PL-type commonly used depending on labeling) rather than vial-based dispensing.
Supplier categories that actually show up in procurement
- Original sterile drug manufacturers (packaged presentations)
- Typically list the admixture (heparin in D5W) as a commercial sterile product in a plastic container.
- Sterile outsourcing and contract manufacturing organizations (CMOs)
- Produce under contract for market-facing branders/distributors, often for hospital systems.
- Authorized distributors
- Stock and ship the commercial NDC. They are not the underlying manufacturer but are the operational suppliers for many procurement teams.
What to look for on the label to match suppliers
- Exact strength format: “heparin sodium 20,000 units …”
- D5W carrier: “in dextrose 5%”
- Total volume in the container (mL) and resulting concentration
- Container description: “plastic container” and the container material family if stated
- NDC on the carton and label (the cleanest match key for supplier mapping)
Which wholesalers and distributors supply heparin sodium in dextrose 5% plastic containers?
Answer: In hospital sourcing, the practical supplier is usually the wholesale distributor that carries the specific NDC presentation, supported by manufacturer allocation and distribution contracts.
Typical distributor channels used for sterile IV admixtures
- National wholesalers (large hospital distribution networks)
- Regional wholesalers for cold-chain and sterile logistics
- Specialty distributors for sterile compounded inventory where applicable
Procurement-relevant constraints
- NDC-specific availability: a distributor may carry the drug but not the exact “20,000 units in D5W plastic container” presentation.
- Package/volume equivalency: substitution is often blocked unless the total units and total volume match label values.
- Storage and shipping: although the product is typically stored refrigerated or room temperature depending on label, shipping lanes and return policies can affect availability.
How do you verify the correct supplier for NDC “Heparin sodium 20,000 units in dextrose 5% in plastic container”?
Answer: Verify by matching the label NDC to the carton and purchase order line item, then tie the NDC to the manufacturer listing from FDA labeling and the distributor listing in your wholesaler catalog.
Validation steps that avoid common mismatches
- Match NDC + package size (often different across volumes)
- Confirm container type (plastic bag) and total volume
- Confirm heparin strength is exactly “20,000 units” per container, not per mL
- Confirm carrier is Dextrose 5% (not NS, not lactated Ringer’s, not heparin-only)
What suppliers compete for hospital tender awards on this presentation?
Answer: Competitive tendering usually occurs at the level of NDC-labeled sterile presentations and fulfillment contracts. Competition is most intense where multiple manufacturers have equivalent labeled formats and where distributors can bid with stable supply.
Tender factors that determine which suppliers can win
- Bid price tied to NDC and package format
- Lead time and allocation history
- Ability to deliver consistent carton quantities
- Substitution policy enforcement (heparin concentration and container volume must align)
What generic or alternative-supplier entry risks exist for heparin sodium in D5W plastic containers?
Answer: Risk is more about presentation equivalence and supply continuity than about a classic generic entry model, because sterile admixture presentations may be locked to specific labeled configurations and manufacturing controls.
Where disruption typically occurs
- Allocation shortages at the manufacturing site
- Container supply constraints (plastic container supply chain)
- Changes in labeled volume, concentration, or container material
How does the “plastic container” packaging affect supplier options and interchangeability?
Answer: Plastic container formats are a procurement gating item. Even if another supplier offers the same total units and D5W carrier, interchangeability can fail if the container volume or container material family differs from tender specs.
Practical interchangeability rules used in procurement
- Same total units per container
- Same D5W carrier
- Same total volume
- Approved substitution list includes only identical or permitted equivalents under hospital policy
Which companies manufacture heparin sodium products and may offer this D5W plastic presentation?
Answer: Many large sterile injectables and anticoagulant suppliers produce heparin sodium across multiple presentations. For this specific admixture (heparin in D5W in plastic), supplier presence is NDC- and formulation-dependent.
Typical upstream supplier footprint
- Firms that produce heparin sodium injection (API and sterile fill-finish)
- Firms with sterile compounding or outsourcing capability for IV admixtures
- Firms with distribution scale for hospital channels
What is the Orange Book status of heparin sodium in D5W plastic containers?
Answer: The Orange Book is the gate for FDA-approved drug exclusivity and listed patents. For a specific combination admixture presentation like this, Orange Book status must be checked by the exact NDC.
What patent litigation affects supplier availability for this presentation?
Answer: Patent litigation can affect availability when it blocks manufacturing, but practical procurement depends far more on NDC-labeled manufacturing authorizations and sterile supply continuity for this admixture.
What regulatory status should be checked before switching suppliers?
Answer: Confirm the product is marketed as the same labeled drug (same NDC). Supplier switching should be conditioned on:
- FDA listing/approval status tied to that NDC
- Current label
- Expiration dating and lot acceptance procedures
- Any REMS or special handling requirements (often none for simple heparin, but container and sterile handling rules still matter)
Supplier mapping table for procurement
Source-of-supply matching requires NDC-level data. The table below is the structure procurement teams use once the NDC is identified.
| Field | What you confirm | Why it matters for supplier selection |
|---|---|---|
| NDC | Exact NDC for “20,000 units in D5W” plastic container | Prevents unit concentration and volume mismatches |
| Labeled strength | 20,000 units per container | Ensures correct anticoagulant dose |
| D5W carrier | Dextrose 5% | Ensures correct fluid composition |
| Container | Plastic container, volume, bag type | Tender spec and interchangeability |
| Manufacturer | Labeled manufacturer/labeler | Determines actual build site |
| Distributor | Wholesaler carrying that NDC | Determines lead time and allocation |
| Lot history | Recent lots supplied | Reduces risk of intermittent shortages |
| Expiration | Shelf life from receipt | Impacts usable inventory and wastage |
Key Takeaways
- Supplier availability for “heparin sodium 20,000 units in Dextrose 5% in plastic container” is NDC- and presentation-specific, not interchangeable at the ingredient level.
- Procurement should treat “plastic container” plus total volume and D5W carrier as non-negotiable matching criteria.
- The practical supplier in hospital operations is typically the wholesaler carrying the exact NDC, backed by the underlying sterile manufacturer.
- Supplier switching risk is primarily driven by presentation equivalence, container supply chain, and lot allocation patterns.
FAQs
-
How do I confirm a substitute for heparin sodium 20,000 units in D5W plastic container is equivalent?
Match NDC, total units per container, D5W carrier, and total volume; reject substitutes that differ in any of these. -
Can I substitute heparin in saline for heparin in dextrose 5%?
Not without clinical and policy approval, because carrier fluid composition changes infusion characteristics and administration protocols. -
What happens if my wholesaler can’t source the plastic container presentation?
Expect tender renegotiation, temporary substitution from an approved equivalent NDC, or order reallocation based on manufacturer allocation. -
What packaging differences create interchangeability problems for sterile heparin admixtures?
Bag volume, container type, and any labeled concentration differences. -
What’s the fastest way to reduce heparin supply disruption risk?
Lock procurement to NDC-specific approved substitutes, maintain safety stock by lot, and coordinate with the wholesaler’s allocation process for the exact presentation.
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