Suppliers and packagers for KENALOG-10

KENALOG-10

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apothecon	KENALOG-10	triamcinolone acetonide	INJECTABLE;INJECTION	012041	NDA	E.R. Squibb & Sons, L.L.C.	0003-0494-20	1 VIAL, MULTI-DOSE in 1 CARTON (0003-0494-20) / 5 mL in 1 VIAL, MULTI-DOSE	2009-06-01
Apothecon	KENALOG-10	triamcinolone acetonide	INJECTABLE;INJECTION	012041	NDA	A-S Medication Solutions	50090-0295-1	1 VIAL, MULTI-DOSE in 1 CARTON (50090-0295-1) / 5 mL in 1 VIAL, MULTI-DOSE	2009-06-01

Kenalog-10 Suppliers: Who Manufactures, Sources, and Distributes Triamcinolone Acetonide Injection 10 mg/mL

Last updated: June 6, 2026

Kenalog-10 (triamcinolone acetonide injectable suspension, 10 mg/mL) is supplied through a defined set of manufacturers and distributors tied to the NDA holder and product distribution network. The supplier landscape depends on (1) the branded product’s current labeled manufacturer, (2) contract manufacturing for sterile injectable suspension, and (3) whether the channel is branded distribution or generic/substitute supply.

What companies supply Kenalog-10 (triamcinolone acetonide injection 10 mg/mL)?

Direct branded supply is anchored to the NDA holder and its commercial distribution partners. In practice, sourcing for clinics and hospitals typically occurs through the product’s authorized distributor network rather than open-market procurement.

What does “supplier” mean for Kenalog-10 in procurement terms?

• NDA holder / marketing authorization holder: controls product label and commercial availability in the US market.
• Primary manufacturer (sterile injectable suspension): manufactures the triamcinolone acetonide suspension and fills/finishes.
• Wholesaler-distributor (channel supplier): delivers the labeled product to provider accounts.
• GPO and specialty distributors: route branded inventory to IDNs and hospital pharmacy systems.

US channel: where procurement typically originates

• National wholesalers: inventory is sourced from the branded manufacturer’s release pipeline.
• GPO contract supply: determines which distributor has “primary” fulfillment under hospital purchasing agreements.
• Hospital “buy-and-bill” workflows: often rely on the same authorized wholesalers that maintain cold-chain and sterile handling compliance, though Kenalog-10 is not a cold-chain product.

Who manufactures the generic and substitute equivalents of Kenalog-10?

Where branded Kenalog-10 is substituted at the point of dispensing, the supplier shifts to the generic manufacturer that is available through the wholesaler network.

What to check to identify substitute suppliers

• NDC labeling for the substitute: each NDC maps to a specific manufacturer and labeler.
• Orange Book listing (if applicable to the specific strength/form): identifies patent and generic status for the active ingredient product.
• Current supply availability by NDC: wholesalers may carry multiple generics for the same dosage form.

What is the Orange Book status of Kenalog-10 (triamcinolone acetonide 10 mg/mL)?

Triamcinolone acetonide products are typically older corticosteroid formulations. For many such injections, the core active ingredient protection has largely expired, so the branded product usually competes with established generics and authorized generics. The practical supplier implication is a mature generic supply base rather than a constrained market.

How Orange Book status impacts supplier availability

• If the branded product has no unexpired formulation or method patents of record for the exact dosage form:
  • Generic suppliers increase.
  • Wholesalers carry multiple manufacturers.
• If a narrow patent exists for a specific formulation characteristic:
  • Some substitutes may be excluded or launch constrained until infringement windows close.

What distributors carry Kenalog-10 and its substitutes (US wholesaler landscape)?

Kenalog-10 distribution is generally routed through large wholesalers that maintain distribution compliance for sterile injectable products.

Typical distributor categories

• National wholesalers with broad hospital coverage
• Regional distributors with stronger specialty allocation
• Pharmacy benefit channel distributors for outpatient settings

Procurement implications

• Supplier lead times depend on:
  • manufacturer batch release timing
  • lot allocations during periods of tight supply
  • GPO contract alignment

How do you identify the exact Kenalog-10 manufacturer behind an order?

The manufacturer is not inferred from the brand name alone. For sterile injectables, the manufacturer identification should be taken from the ordered NDC.

Procurement mapping approach

1. Record the exact NDC on the label or invoice line item.
2. Match NDC to the labeled manufacturer (labeler/manufacturer field in product listing databases).
3. Confirm whether the item is:
   • branded Kenalog-10
   • a generic triamcinolone acetonide injection
   • an authorized generic or substitute with the same strength and dosage form

What manufacturing/IP barriers affect who can supply Kenalog-10?

For mature corticosteroid injections, the barriers are usually operational, not IP-driven.

Sterile suspension manufacturing constraints

• sterile injectable suspension requirements
• formulation consistency (particle size distribution, viscosity)
• aseptic fill-finish capacity
• regulatory quality system maturity and lot release capacity

How these barriers show up in supplier lists

• fewer suppliers during shortages
• reliance on contract fill-finish capacity
• “best available” allocation through wholesalers

Which Kenalog-10 formulations can suppliers provide (10 mg/mL suspension only)?

Supplier scope depends on matching the labeled product characteristics:

• strength: 10 mg/mL
• dosage form: injectable suspension (not solution)
• route: intramuscular, intra-articular, intralesional (as indicated on labeling)
• container: commonly vial presentations (exact fill volume depends on the NDC)

When do supply shortages change the effective supplier roster?

When supply tightens, wholesaler allocations can temporarily shift to alternate NDCs or additional generic manufacturers.

What triggers roster changes

• batch release delays at a key fill-finish site
• quality investigation outcomes affecting lot release
• increased demand spikes in dermatology, rheumatology, and orthopedic inflammation management

Key Takeaways

• Kenalog-10 supplier determination is NDC-specific: the active ingredient brand name does not identify the manufacturing site.
• Branded supply flows through authorized distributors tied to the NDA holder and its release schedule.
• Substitute supply typically comes from a mature generic ecosystem once branded exclusivities expire for the relevant dosage form.
• The most reliable way to identify “who supplies” for procurement is to map the NDC to the labeled manufacturer and confirm whether the product line is branded or substituted.

FAQs

1. How can I confirm the manufacturer of Kenalog-10 on a hospital purchase order?
   Use the exact NDC from the invoice line item and map it to the labeled manufacturer.
2. Can Kenalog-10 be substituted with other triamcinolone acetonide injections?
   Yes, substitution depends on matching strength, dosage form, and NDC-validated interchangeability in the dispensing workflow.
3. Do Kenalog-10 generic suppliers differ by vial size or presentation?
   Yes. Even within the same strength, different vial fill volumes and NDCs can correspond to different manufacturers.
4. What causes Kenalog-10 allocation through wholesalers?
   Typically lot release delays, sterile manufacturing capacity constraints, or quality system investigations.
5. Do patent protections affect who can supply Kenalog-10 today?
   For many older corticosteroid injections, active ingredient and formulation protections are usually expired or narrow, so supplier availability is driven mostly by manufacturing capacity and regulatory status of specific NDCs.

References

1. United States FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA Drug Labeling Resources. (Accessed via DailyMed / SPL labeling for triamcinolone acetonide injectable suspension).