Prescription drug · ANDA
Fluorescein NDC 14789-123
Fluorescein 250 mg/mL · Injection · Intravenous · Nexus Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14789-123-05 | 14789012305 | 10 VIAL in 1 CARTON (14789-123-05) / 2 mL in 1 VIAL (14789-123-07)Marketed from Oct 24, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Fluorescein
- Generic name (nonproprietary)
- fluorescein
- Active ingredients
- Fluorescein — 250 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Nexus Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215709
- Marketing start
- Listing expires
- Other FDA classes
- Dyes (Mechanism)
- Identifiers
- Product ID 14789-123_b66b331e-c90a-48e0-9d9d-961c1cb5c9e2SPL ID b66b331e-c90a-48e0-9d9d-961c1cb5c9e2SPL set ID 0a2a65b1-dc88-445b-bfb7-53b2fd7bea2cUNII TPY09G7XIRUPC 0314789122052
- 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
N414789012305followed by a unit qualifier and the quantityPackage 14789-0123-05. 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)
1. INDICATIONS & USAGE Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP 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 ANDA 215709
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 500 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-122 |