Prescription drug · ANDA
Fluorescein NDC 70771-1970
Fluorescein sodium 250 mg/mL · Injection · Intravenous · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1970-9 | 70771197009 | 12 VIAL, SINGLE-DOSE in 1 CARTON (70771-1970-9) / 2 mL in 1 VIAL, SINGLE-DOSE (70771-1970-1)Marketed from Jun 2, 2026 |
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 — 250 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218651
- Marketing start
- Listing expires
- Other FDA classes
- Dyes (Mechanism)
- Identifiers
- Product ID 70771-1970_1fa59f77-0f1a-4b92-b438-1b20853c967dSPL ID 1fa59f77-0f1a-4b92-b438-1b20853c967dSPL set ID 5c88e2a2-b05c-46f2-9874-c935e4b96a6eUNII 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
N470771197009followed by a unit qualifier and the quantityPackage 70771-1970-09. 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 .
Other NDCs under ANDA 218651
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 | Zydus Lifesciences Limited | 70771-1969 |
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2045 |
| Fluorescein | Fluorescein sodium 250 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2046 |