Prescription drug · ANDA
Fluorescein NDC 70710-2045
Fluorescein sodium 100 mg/mL · Injection · Intravenous · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-2045-9 | 7071020450970710204509 | 12 VIAL, SINGLE-DOSE in 1 CARTON (70710-2045-9) / 5 mL in 1 VIAL, SINGLE-DOSE (70710-2045-1)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 — 100 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- 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 70710-2045_1c836bea-abb2-4edc-83bf-d82f74bf8e2dSPL ID 1c836bea-abb2-4edc-83bf-d82f74bf8e2d
- 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
N470710204509followed by a unit qualifier and the quantityPackage 70710-2045-09. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70710-2045
- What is NDC 70710-2045?
- 70710-2045 is the product NDC for Fluorescein, Fluorescein sodium 100 mg/mL injection, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 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 |
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1533 | 51662-1533-03 |
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 250 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2046 |
| Fluorescein | Fluorescein sodium 100 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1969 |
| Fluorescein | Fluorescein sodium 250 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1970 |