Prescription drug · ANDA
Fluorescein NDC 14789-122
Fluorescein 500 mg/mL · Injection · Intravenous · Nexus Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14789-122-05 | 1478901220514789012205 | 10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)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 — 500 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Nexus Pharmaceuticals LLCNDC labeler code 14789
- 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 14789-122_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
N414789012205followed by a unit qualifier and the quantityPackage 14789-0122-05. 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.
About NDC 14789-122
- What is NDC 14789-122?
- 14789-122 is the product NDC for Fluorescein, Fluorescein 500 mg/mL injection, listed with the FDA by Nexus Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluorescein.
- What is the active ingredient?
- Fluorescein.
- Who is the labeler?
- Nexus Pharmaceuticals LLC, NDC labeler code 14789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluorescein?
- 7 other product NDCs are listed under this name. See all Fluorescein NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluorescein products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2045 | 70710-2045-09 |
| Fluorescein | Fluorescein sodium 250 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2046 | 70710-2046-09 |
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1969 | 70771-1969-09 |
| Fluorescein | Fluorescein sodium 250 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1970 | 70771-1970-09 |
| Fluorescein | Fluorescein sodium 500 mg/5mL | Injection, SolutionIntravenous | BPI Labs LLC | 54288-179 | 54288-0179-10 |
| Fluorescein | Fluorescein 250 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-123 | 14789-0123-05 |
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1533 | 51662-1533-03 |
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 250 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-123 |