Last updated: April 25, 2026
Who supplies PLASMA-LYTE A in plastic container?
Suppliers of record for PLASMA-LYTE A (plasma-lyte A) in a plastic container are the manufacturers and packagers listed on the product’s labeling and in the FDA’s drug registration datasets. Those identifiers are what determine procurement, GMP responsibility, and change-control ownership for the finished sterile solution in the container.
What “PLASMA-LYTE A in plastic container” suppliers exist in official FDA-facing data?
| Supplier role |
Entity type |
What to verify in labeling / FDA datasets |
Typical identifiers used in sourcing |
| Finished drug manufacturer |
Company that manufactures the sterile solution |
“Manufactured for” / “Manufactured by” on carton and label; NDC labeler and manufacturer fields |
NDC labeler code, company name tied to manufacturing site |
| Packager / relabeler (if different) |
Company that packages into the plastic container |
“Packaged by” or “Distributed by”; site tied to packaging operations |
NDC labeler code vs. manufacturer code |
| Container supplier (primary packaging) |
Company providing the plastic container system |
Often addressed in device/container vendor documentation; may not be named on patient-facing label |
Container material and configuration on regulatory/validation docs |
| Logistics distributor |
Wholesaler/distributor |
“Distributed by” on label; not the manufacturer of record |
Distributor name and address on label |
Which specific suppliers can be named?
No complete, accurate supplier list can be produced from the information provided. “Suppliers” can mean (1) the labeled manufacturer of record, (2) packager, (3) container vendor, or (4) distributor/wholesaler. Without the exact product identity keys (for example, the NDC(s) tied to the plastic container configuration), a correct supplier roster cannot be generated without risk of mixing different labeler/manufacturer configurations.
How to treat “plastic container” in sourcing
What container configuration changes supplier mapping?
In sterile IV solutions, the plastic container format commonly maps to specific NDC labeler/manufacturer combinations and sometimes different secondary packaging and logistics. Your sourcing team should key off the NDC and label strength/package line item used for procurement, then map to:
- Finished drug manufacturer and packager (GMP responsibility)
- NDC labeler (who is accountable to FDA for listing)
- Lot release chain (which entity’s Quality Unit releases the finished product)
What procurement artifacts identify the supplier
Use these artifacts for supplier confirmation:
- Carton and vial/bag label: “Distributed by,” “Manufactured for,” “Manufactured by,” and addresses.
- NDC directory record for the specific NDC tied to the plastic container.
- Drug establishment registration (manufacturer site) for the company name on labeling.
Key Takeaways
- Supplier identification for PLASMA-LYTE A in plastic containers requires the exact NDC/package configuration and the manufacturer fields on FDA-facing records and product labeling.
- “Suppliers” can mean different entities (finished manufacturer vs. distributor vs. container vendor); only the labeling/FDA-listed manufacturer of record can be treated as a reliable supplier for procurement and change-control decisions.
- Use NDC-keyed mapping to avoid mixing manufacturer and labeler configurations across container formats.
FAQs
1) Are the manufacturer of record and distributor the same for PLASMA-LYTE A?
Often they differ: the label can show “Distributed by” as a different entity than “Manufactured for” or “Manufactured by.” Only the manufacturer-of-record fields define GMP responsibility.
2) Does the plastic container itself have a named supplier on the label?
Not consistently. The patient-facing label typically identifies the drug manufacturer/distributor, not the plastic bag container vendor.
3) How do I avoid mixing suppliers across different PLASMA-LYTE A presentations?
Key procurement strictly to the exact NDC for the plastic container presentation, then map to the corresponding manufacturer/labeler in FDA listings.
4) Which FDA dataset is the authoritative source for the finished drug manufacturer?
The FDA drug labeling/NDC listing and the linked drug establishment registration are the primary sources for manufacturer-of-record mapping.
5) If two companies share the same NDC, are they interchangeable suppliers?
No. Even when labeler/manufacturer information appears similar, operational responsibility is determined by the exact manufacturer site registered for that product presentation and lot release chain tied to the NDC.
References
[1] FDA. Drug Registration and Listing System (DRLS). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-registration-and-listing-drug-products
[2] FDA. National Drug Code (NDC) Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-labeling-and-databases/ndc-directory
