Prescription drug · NDA
Fluorescein NDC 51662-1533
Fluorescein sodium 100 mg/mL · Injection · Intravenous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1533-3 | 51662153303 | 12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from May 10, 2021 |
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)
- Fluorescein
- Generic name (nonproprietary)
- fluorescein
- Active ingredients
- Fluorescein sodium — 100 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022186
- Marketing start
- Listing expires
- Other FDA classes
- Dyes (Mechanism)
- Identifiers
- Product ID 51662-1533_c915cb71-f04b-2377-e053-2995a90a5d92SPL ID c915cb71-f04b-2377-e053-2995a90a5d92SPL set ID c1ffe119-7fba-940f-e053-2a95a90a7a17UNII 93X55PE38X
- 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
N451662153303followed by a unit qualifier and the quantityPackage 51662-1533-03. 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)
1. INDICATIONS & USAGE AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
Excerpt only. Read the full label for complete information.
About NDC 51662-1533
- What is NDC 51662-1533?
- 51662-1533 is the product NDC for Fluorescein, Fluorescein sodium 100 mg/mL injection, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. 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 sodium.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 500 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-122 | 14789-0122-05 |
| Fluorescein | Fluorescein 250 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-123 | 14789-0123-05 |
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 |
|---|---|---|---|---|
| Ak-Fluorfluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | Long Grove Pharmaceuticals, LLC | 81298-8660 |