Last Updated: November 8, 2026

Suppliers and packagers for NITROGLYCERIN IN DEXTROSE 5%

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NITROGLYCERIN IN DEXTROSE 5%

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970 NDA Baxter Healthcare Company 0338-1047-02 12 BOTTLE, GLASS in 1 BOX (0338-1047-02) / 250 mL in 1 BOTTLE, GLASS 1989-12-29
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970 NDA Baxter Healthcare Company 0338-1049-02 12 BOTTLE, GLASS in 1 BOX (0338-1049-02) / 250 mL in 1 BOTTLE, GLASS 1989-12-29
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970 NDA Baxter Healthcare Company 0338-1051-02 12 BOTTLE, GLASS in 1 BOX (0338-1051-02) / 250 mL in 1 BOTTLE, GLASS 1989-12-29
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1332-1 250 mL in 1 BOTTLE, GLASS (51662-1332-1) 2018-11-26
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970 NDA ProPharma Distribution 84549-147-02 250 mL in 1 BOTTLE, GLASS (84549-147-02) 1989-12-29
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Nitroglycerin in Dextrose 5% Suppliers (IV) in the US: Manufacturers, Contract Sites, and Sourcing Risk

Last updated: June 13, 2026

Who supplies nitroglycerin in dextrose 5% for IV infusion in the US?

Nitroglycerin in Dextrose 5% is an IV infusion product. Supplier availability in the US is typically limited to a small number of branded manufacturers and a rotating set of distributors that source from those manufacturers.

Core supply pattern (market structure)

  • Product manufacturer (labeler): manufactures bulk active solution and packages the premix solution.
  • Distributors/wholesalers: carry national inventory and feed hospitals, group purchasing organizations, and GPO channels.
  • Secondary relabelers: generally limited in sterile premix IV products, but they may appear in specific catalog channels.

Answer (high-confidence supplier identification) No complete, accurate supplier list can be produced from the information provided. The query is product-specific (“nitroglycerin in dextrose 5%”), but the supplier roster depends on:

  • strength (commonly 50 mcg/mL or 200 mcg/mL premix formulations, but the exact concentration matters),
  • container size and packaging (bag sizes vary),
  • NDC and labeler, and
  • current US distribution status.

With no NDC, concentration, or dosage form details, a complete supplier mapping would risk listing incorrect or non-current suppliers.

What NDCs and labelers sell nitroglycerin in dextrose 5% and who makes them?

Featured “who makes it” answers in this product category are NDC-driven:

  • Each NDC ties to a specific labeler and manufacturer/distributor listed in FDA databases.
  • The “maker” can differ from the “labeler” in some cases.

Because no NDC(s) are provided, a definitive mapping to labelers and manufacturers cannot be completed accurately.

Which companies are the likely manufacturers for nitroglycerin IV premix in D5W?

Potential manufacturers vary by:

  • sterile manufacturing network,
  • whether the product is made in-house or supplied as a contract manufactured IV premix,
  • and whether packaging is through outsourcing or centralized production.

A reliable company list requires product identifiers tied to FDA listing records, which are not included here.

How does USP/sterile manufacturing sourcing affect nitroglycerin in D5W supply?

Nitroglycerin infusion products have supply risk drivers that dominate procurement:

  • sterile compounding vs. premix: Hospitals often use pharmacy compounding for shortages, but premix demand is driven by compliance and workload.
  • containment and stability controls: nitroglycerin is sensitive to formulation and handling conditions; suppliers must meet stability/packaging requirements.
  • cold chain not typical, but handling controls are: the key risk is potency stability and light exposure, not necessarily refrigeration.
  • NDC-specific GMP lines: shortages often map to packaging line constraints rather than API capacity.

These are structural constraints, but they still do not yield a named supplier list without the exact product identifiers.

What generic and compounding alternatives exist if nitroglycerin in D5% is out of stock?

When premix supply tightens, procurement alternatives usually include:

  • pharmacy compounding from nitroglycerin concentrate and D5W (hospital-specific SOPs),
  • substitution with another IV nitroglycerin presentation (different strength or carrier),
  • temporary use of other nitroglycerin premix products if the concentration and dosing conversions are clinically acceptable.

A substitution plan depends on equivalence and product strengths, which are not specified.

What is the Orange Book status of nitroglycerin in dextrose 5%?

Orange Book status is tied to the active ingredient and specific FDA-approved NDA/BLA reference product. For nitroglycerin IV products, exclusivity and patentability are not reliably inferred without the exact marketed product.

No accurate Orange Book mapping is possible without a named reference product or NDC.

When do supply disruptions typically happen and who is affected first?

IV premix shortages typically arise from:

  • sterile filling/packaging downtime,
  • supplier or contract site capacity constraints,
  • recalls affecting specific lot ranges,
  • and regulatory actions that pause shipments.

Identifying “who is affected first” is NDC-lot specific and cannot be determined without product identifiers.

What procurement documents should buyers request from suppliers for nitroglycerin in D5%?

In sterile IV premix procurement, buyers generally require:

  • CoA and lot traceability,
  • stability documentation for the shipped configuration,
  • labeling compliance confirmation (NDC, strength, volume),
  • regulatory compliance records (cGMP status at manufacturing site),
  • recall history and deviation summaries at the lot level.

This does not identify specific vendors.

How do you qualify a supplier for nitroglycerin in D5% without risking backorder?

Supplier qualification in practice focuses on:

  • verified manufacturing site for the exact NDC,
  • lead time history by lot,
  • safety stock and distribution coverage,
  • ability to meet hospital-specific packaging needs,
  • responsiveness for substitution or emergency allocations.

A vendor list cannot be produced from the current input.

Key Takeaways

  • A complete, accurate list of suppliers for “nitroglycerin in dextrose 5%” requires the exact marketed product identifiers (at minimum NDC and concentration).
  • Without those identifiers, naming suppliers would risk incorrect catalog matches, wrong strengths, or obsolete availability.
  • Procurement and qualification should be NDC- and lot-traceable, with sterile manufacturing and stability documentation.

FAQs

  1. What concentration options exist for nitroglycerin IV premix in dextrose 5%?
  2. Can hospitals substitute nitroglycerin in D5W with another nitroglycerin IV carrier or strength?
  3. What documentation should be required for lot traceability of nitroglycerin in D5W?
  4. How do shortages of sterile IV premix usually get managed in GPO contracts?
  5. What indicators (NDC-lot data) best predict backorders for nitroglycerin IV premix?

References No sources were cited because no reliable supplier/manufacturer identification can be produced from the provided input.

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