Suppliers and packagers for LANOXIN PEDIATRIC

LANOXIN PEDIATRIC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	LANOXIN PEDIATRIC	digoxin	INJECTABLE;INJECTION	009330	NDA	Covis Pharma US, Inc	70515-261-10	10 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIAL	2019-10-29
Azurity	LANOXIN PEDIATRIC	digoxin	INJECTABLE;INJECTION	009330	NDA	Covis Pharma US, Inc	70515-263-10	10 VIAL in 1 BOX (70515-263-10) / 1 mL in 1 VIAL	2019-10-29

LANOXIN PEDIATRIC Suppliers and Supply Chain: Who Manufactures Digoxin Oral Solution and Who Controls Upstream Inputs

Last updated: June 14, 2026

LANOXIN PEDIATRIC is digoxin oral solution. The supply base is concentrated around the digoxin API manufacturer(s) used by the branded formulation maker and the contract manufacturing and packaging sites that produce and distribute the marketed oral product. The actionable supplier map depends on the specific labeled strength and package configuration listed under the FDA product record for LANOXIN PEDIATRIC.

Which companies supply digoxin API used for LANOXIN PEDIATRIC?

LANOXIN PEDIATRIC is not an API product category in FDA listing terms. It is a finished pharmaceutical product whose manufacturer can vary by labeler, contract holder, and packaging site over time. Digoxin API supply is therefore best assessed through the finished product’s listed manufacturers (drug product) and then upstream API sources used for that specific NADAs/NDAs’ manufacturing history.

What typically defines the supplier set

• Finished drug product manufacturers (site-level) that produce the oral solution.
• Fill and finish and packaging sites (bottling, closures, labeling).
• Upstream digoxin API manufacturers supplying the formulation plant.

Key constraint for supplier accuracy Without the exact FDA labeler/NDC-to-manufacturer mapping for the specific LANOXIN PEDIATRIC presentation, any list of “suppliers” would risk mixing different digoxin products, different labelers, and different manufacturing sites.

What is the Orange Book status of LANOXIN PEDIATRIC and what does it imply for supply?

Featured snippet answer: LANOXIN PEDIATRIC’s exclusivity and patent landscape is determined by the underlying digoxin oral solution NDA listing. Generic entry timing and patent challenges determine whether multiple finished-product suppliers can legally market equivalent products.

Why Orange Book matters for suppliers

• If the marketed product has limited protection, multiple generic manufacturers can compete on finished drug supply.
• If protection remains in force, only the brand and its authorized suppliers can reliably source finished product.

How to connect Orange Book listings to supplier identification

A practical supplier workflow uses:

• FDA Orange Book listing for the relevant NDA (drug product and strength).
• FDA labeler/manufacturer and site fields for the listed NDC.
• Patent expiry and exclusivity windows that signal whether generics can supply the same dose form.

How do you identify the actual finished-product manufacturer of LANOXIN PEDIATRIC?

Featured snippet answer: Use the FDA drug product listing (labeler and establishment) attached to the exact NDC for the specific LANOXIN PEDIATRIC oral solution presentation.

What to capture for a defensible supplier map

• NDA holder (marketing authorization holder).
• Labeler(s) on the NDC.
• Manufacturing establishment(s) for drug product and for packaging.
• Revision history showing transfers or site additions.

Typical supplier roles in oral solution supply

• Drug product manufacturer: bulk solution preparation, compounding, sterilization status (oral solutions are typically non-sterile), filtration steps, and final bulk holds.
• Fill-finish: filling into bottles, applying closures, secondary packaging.
• Quality release and distribution: lot release, warehousing, and distribution networks.

Are there generic or authorized equivalents to LANOXIN PEDIATRIC that change the supplier list?

Featured snippet answer: If generics are listed for the same dose form and strength, the supplier set expands from the brand’s authorized manufacturers to multiple ANDA/authorized generic finished-product makers.

What changes when generics are available

• More manufacturers for finished product (drug product plants and packaging sites).
• More API procurement flexibility at the formulation level.
• More storage and logistics variability across NDCs.

When can new suppliers enter for LANOXIN PEDIATRIC?

Featured snippet answer: New finished-product suppliers for the same oral digoxin solution typically enter around ANDA approval timelines once exclusivities and listed patent barriers are cleared for the relevant NDA.

Timing drivers

• Orange Book patent expiry and exclusivity windows tied to the NDA.
• FDA approval dates for ANDAs and any litigation-driven design changes.
• Market authorization for alternate strengths or packaging configurations.

What manufacturing and IP barriers affect LANOXIN PEDIATRIC supply?

Featured snippet answer: The main barriers are NDA-specific formulation and manufacturing know-how protected by patents (if any) and any regulatory review constraints related to bioequivalence or specification control.

Barriers most likely to matter

• Formulation control (stability of digoxin in solution, pH/excipient system).
• In-process controls (assay uniformity, potency drift).
• Container-closure system compatibility (leachables/extractables and adsorption).
• Labeling and dosing accuracy for pediatric use.

What is the competitive landscape for pediatric oral digoxin supply?

Featured snippet answer: Pediatric oral digoxin supply generally tracks the availability of digoxin oral solution products and whether dose delivery meets pediatric labeling and dosing instructions.

Supplier landscape in practice

• Brand LANOXIN PEDIATRIC (if still marketed for the relevant NDC).
• One or more generic digoxin oral solutions marketed by different ANDA holders.
• Pharmacy distribution intermediaries that determine effective “who supplies my patients” at the channel level.

Key takeaways

• LANOXIN PEDIATRIC is digoxin oral solution; supplier mapping depends on the exact NDC and the FDA listing that ties that NDC to a specific drug product manufacturing site and packaging sites.
• Orange Book status determines whether the market is brand-only or shared with generics/authorized equivalents, which directly changes the supplier universe.
• A defensible supplier list requires NDC-level identification of the labeled manufacturer and then tracing upstream API sourcing via that product’s manufacturing history.

FAQs

1. How do I find the exact NDC-level manufacturer for LANOXIN PEDIATRIC?
2. Which generics are therapeutically equivalent to LANOXIN PEDIATRIC (digoxin oral solution) for pediatric dosing?
3. Do patent expirations for digoxin oral solutions affect who can supply LANOXIN PEDIATRIC?
4. What container-closure and formulation controls matter most for digoxin oral solution stability?
5. How can I assess whether current supply risk is driven by API shortages or by finished-product fill-finish capacity?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA Drug Registration and Listing System (DRLS). U.S. Food and Drug Administration.