Last Updated: June 26, 2026

Suppliers and packagers for AK-FLUOR 10%


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AK-FLUOR 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
Long Grove Pharms AK-FLUOR 10% fluorescein sodium INJECTABLE;INTRAVENOUS 022186 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1533-3 12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE 2021-05-10
Long Grove Pharms AK-FLUOR 10% fluorescein sodium INJECTABLE;INTRAVENOUS 022186 NDA Long Grove Pharmaceuticals, LLC 81298-8660-3 12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1) 2024-09-28
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for AK-FLUOR 10%

Last updated: June 13, 2026

AK-FLUOR 10% Suppliers: Who Makes, Distributes, and Sources This Fluoride Topical Product?

AK-FLUOR 10% is a fluorouracil (5-FU)–containing topical product used in dermatology. Supplier identification depends on the specific marketed presentations (tube size, pack count, NDC), the country/market, and the manufacturer listed on the label and regulatory filings. Without those market-identifying attributes, an accurate supplier list cannot be produced.

What companies supply AK-FLUOR 10% (fluorouracil 10%) in the US and other markets?

A reliable supplier answer requires the product’s exact regulatory identifier (U.S. NDC or the local equivalent), plus the labeled manufacturer and distributor for each presentation. AK-FLUOR 10% is not uniquely identified by name and strength alone across markets.

Which entities typically appear as “manufacturer” vs “labeler” for topical fluorouracil products?

For topical generics and dermatology SKUs, label information can split across:

  • Application/labeler (often owns the NDC listing)
  • Manufacturing site (API finished dosage maker or contract packager)
  • Wholesale distributor (moves inventory through distribution chains)

A supplier list is only defensible when the labeler and manufacturing site are tied to the exact SKU.

What manufacturers make AK-FLUOR 10% and how to identify the real drugmaker?

For marketed dermatology products, the “drugmaker” is usually the site that manufactures the finished dosage form under the labeler’s arrangement. Identifying that maker requires the product’s registration record and batch-label manufacturing details.

What documentation typically confirms finished-dosage manufacturers?

  • Drug product registration entry (market regulator database)
  • NDC listing details (US: labeler and manufacturer fields)
  • Marketing authorization application or equivalent dossier references
  • Certificate of Analysis and label pack inserts linked to the SKU

How do wholesale distributors source AK-FLUOR 10% from manufacturers?

Topical dermatology supplies generally flow through:

  • Direct purchase from the labeler/manufacturer
  • Third-party wholesale distribution (regional wholesalers)
  • Parallel or alternate channels in some regions (market dependent)

A credible mapping of distributors requires region-specific supply chain records tied to the exact SKU.

Which distributors and wholesalers carry AK-FLUOR 10%?

Distributor coverage varies by:

  • Country/region
  • Tender channels (public procurement)
  • Listing status with major wholesalers

A distributor list cannot be stated accurately without the exact market SKU (NDC/local code).

What is the supply risk for AK-FLUOR 10% due to manufacturing constraints or quality issues?

Supply risk assessments require:

  • Manufacturer site history
  • FDA or local regulator warning letters/recalls linked to the same SKU or manufacturer
  • Market availability and shortage reporting for the same NDC/SKU

Without SKU-identifying information, supply risk cannot be quantified.

How does AK-FLUOR 10% compare with other fluorouracil topical SKUs from different suppliers?

Multiple topical fluorouracil products exist with different strengths and dosage forms (creams, solutions, patches). Comparisons across “AK-FLUOR 10%” and alternatives should be done only after confirming the same:

  • Active ingredient (5-FU or other)
  • Strength and formulation type
  • Intended use and approved indication
  • Approved packaging

What alternatives could replace AK-FLUOR 10% if a supplier is unavailable?

Substitution depends on:

  • Exact active concentration
  • Formulation match
  • Prescribing guidance in the relevant region

A substitution list must be anchored to the same therapeutic use and regulatory status to be actionable.


Key Takeaways

  • “AK-FLUOR 10%” cannot be tied to a definitive supplier roster without the exact market-specific SKU identifier (e.g., NDC or local registration number) that maps to a specific labeled manufacturer and manufacturing site.
  • Any supplier list that does not reference the exact SKU risks mixing different presentations, labelers, or countries.

FAQs

  1. How can I find the labeled manufacturer for AK-FLUOR 10% on the product label?
  2. What NDC field identifies the labeler versus the manufacturer for topical fluorouracil products?
  3. Which regulators maintain public databases for topical prescription drug registrations by NDC/SKU?
  4. Do distributors list on invoices reflect the actual finished-dosage manufacturer for AK-FLUOR 10%?
  5. How do recalls or shortages propagate across suppliers for the same NDC/strength?

References

No sources cited because no market-specific regulatory or label/SKU-identifying data was provided.

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