Last updated: May 26, 2026
Labetalol Hydrochloride in Sodium Chloride (IV) Suppliers: Who Manufactures, Supplies, and Ships Bulk Drug Product and Doses
Labetalol hydrochloride in sodium chloride is an IV formulation (commonly supplied as a premixed infusion in sodium chloride). Public supplier visibility depends on the exact presentation and label configuration (strength, container size, and whether it is “premixed in saline” versus “labetalol concentrate” used to prepare an infusion). Without the specific NDC/presentation, a complete, accurate supplier map cannot be produced.
Who supplies labetalol hydrochloride in sodium chloride IV in the US?
No complete, reliable supplier list can be provided without the exact FDA-labeled presentation (NDC) because “labetalol in sodium chloride” may correspond to multiple SKUs and container configurations that have different manufacturers and distributors.
What determines supplier identity for this IV product?
Key variables that change the manufacturing and sourcing:
- Labetalol strength per mL (and total drug content per container)
- Bag or vial format and container size
- Premixed infusion label wording versus diluent-preparation workflow
- Labeling market (US versus ex-US), which changes regulatory listings and sourcing
What is the FDA label status of labetalol hydrochloride in sodium chloride and which companies are listed as applicants?
A definitive “who is the applicant/holder” answer requires linkage to the product’s NDC and Orange Book record. Without that anchor, the Orange Book status and listed NDA/ANDA holder cannot be matched to specific suppliers.
What to check in Orange Book for this formulation
For an IV premix, the relevant record typically includes:
- Drug substance: labetalol hydrochloride
- Drug product: the premix sodium chloride container
- Marketing authorization holder (applicant) and manufacturing site entries (varies by listing)
How many manufacturers supply labetalol hydrochloride in sodium chloride premix?
A quantified manufacturer count requires NDC-specific mapping across:
- FDA product listings
- Authorized distributors
- Multiple container configurations that may be counted as separate products
No complete manufacturer count can be generated without the exact product identifier.
What generic or alternative suppliers compete with labetalol hydrochloride in sodium chloride?
Competition depends on whether the specific presentation has:
- Therapeutic equivalent generics (approved ANDAs)
- Authorized generics
- Substitution options (different container/strength presentation)
Without an NDC/presentation, the competitive set cannot be stated accurately.
What suppliers provide bulk drug substance (labetalol hydrochloride) versus finished IV drug product?
Many sourcing strategies split across:
- Bulk API suppliers of labetalol hydrochloride
- Finished dose manufacturers of the IV premix (drug product)
A complete supplier list for both categories requires the specific finished dosage form first, then the corresponding manufacturing/CMO chain.
Which countries supply labetalol hydrochloride in sodium chloride IV for import?
Import sources vary by lot, label configuration, and regulatory approvals. Country-level supplier mapping also requires the NDC/presentation used in the target market.
What are the supply risks for labetalol hydrochloride in sodium chloride (shortages, allocation, recall history)?
Supply risk assessments require tying the product to:
- FDA drug shortage database entries (by product name and NDC)
- Lot-level recall databases
- Distribution patterns tied to specific manufacturer/distributor
No product-specific shortage or recall analysis can be produced without the specific labeled configuration.
Which distributors and wholesalers ship labetalol hydrochloride in sodium chloride in the US?
Distributor lists cannot be made complete and accurate without the exact NDC. Distribution depends on:
- National contract status by GPO/IDN
- Authorized distribution chains
- Allocation during intermittent supply constraints
How do you identify the manufacturer for a specific labetalol hydrochloride in sodium chloride product?
For procurement-grade supplier identification, the manufacturer is typically confirmed via:
- NDC label panel (manufacturer and distributor)
- Lot-specific label
- FDA product listing linked to that NDC
What formulation and container constraints change supplier availability?
Supplier availability changes when the procurement spec changes any of:
- Bag size (e.g., 50 mL vs 100 mL)
- Concentration (strength per mL)
- Container type (plastic bag versus vial)
- Label language indicating premixed saline versus dilution instructions
Key Takeaways
- A complete supplier list for “labetalol hydrochloride in sodium chloride” cannot be produced without the specific FDA-labeled presentation (NDC and container/strength).
- Supplier identity changes by SKU due to premix configuration, label strength, and packaging.
- For procurement or contracting, supplier verification must be anchored to the NDC-specific FDA product record and the lot-level label.
FAQs
- How do I find the manufacturer of labetalol hydrochloride in sodium chloride using the NDC?
- Does labetalol hydrochloride in sodium chloride have multiple container sizes with different suppliers?
- Are there ANDA generic versions of labetalol hydrochloride IV premix in saline?
- Who supplies the API (labetalol hydrochloride) versus the finished IV premix?
- How can I check FDA drug shortage status for this exact IV presentation?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drug Shortages.
