Prescription drug · NDA
Ak-Fluor (fluorescein) NDC 81298-8660
Fluorescein sodium 100 mg/mL · Injection · Intravenous · Long Grove Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81298-8660-3 | 81298866003 | 12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)Marketed from Sep 28, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ak-Fluor
- Generic name (nonproprietary)
- fluorescein
- Active ingredients
- Fluorescein sodium — 100 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022186
- Marketing start
- Listing expires
- Other FDA classes
- Dyes (Mechanism)
- Identifiers
- Product ID 81298-8660_ceefeb58-5c89-4157-a0bc-8a1409dc3873SPL ID ceefeb58-5c89-4157-a0bc-8a1409dc3873SPL set ID 73511e79-c050-4dc0-aa2f-a79ed320b5b0UNII 93X55PE38XUPC 0381298866036
- Pharmacologic class
- Diagnostic Dye
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481298866003followed by a unit qualifier and the quantityPackage 81298-8660-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
AK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022186
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1533 |