Prescription drug · ANDA
Prednisolone Acetate NDC 50090-7539
Prednisolone acetate 10 mg/mL · Suspension/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7539-0 | 50090753900 | 1 BOTTLE in 1 CARTON (50090-7539-0) / 5 mL in 1 BOTTLEMarketed from Apr 22, 2025 |
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)
- Prednisolone Acetate
- Generic name (nonproprietary)
- prednisolone acetate
- Active ingredients
- Prednisolone acetate — 10 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216935
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50090-7539_af502300-c29e-405b-bb6f-f125d432a2c1SPL ID af502300-c29e-405b-bb6f-f125d432a2c1SPL set ID f0e1b691-73ff-49ee-8a3c-71769b284ab8RxCUI 1376336UNII 8B2807733D
- Pharmacologic class
- Corticosteroid
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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090753900followed by a unit qualifier and the quantityPackage 50090-7539-00. 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)
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216935
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 |
|---|---|---|---|---|
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Lupin Pharmaceuticals, Inc. | 70748-332 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Redpharm Drug | 67296-2176 |