Prescription drug · NDA AUTHORIZED GENERIC
Prednisolone Acetate NDC 76420-204
Prednisolone acetate 10 mg/mL · Suspension/ drops · Ophthalmic · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-204-05 | 7642002040576420020405 | 1 BOTTLE, DROPPER in 1 CARTON (76420-204-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 30, 2021 |
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)
- Prednisolone Acetate
- Generic name (nonproprietary)
- prednisolone acetate
- Active ingredients
- Prednisolone acetate — 10 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017011
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76420-204_d1fbb852-8bc5-7a0e-e053-2a95a90a2d8eSPL ID d1fbb852-8bc5-7a0e-e053-2a95a90a2d8eSPL set ID 232e40a5-17c5-4cf3-9e3b-110a194ad4beRxCUI 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
N476420020405followed by a unit qualifier and the quantityPackage 76420-0204-05. 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)
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension 1% 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.
About NDC 76420-204
- What is NDC 76420-204?
- 76420-204 is the product NDC for Prednisolone Acetate, Prednisolone acetate 10 mg/mL suspension/ drops, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prednisolone Acetate.
- What is the active ingredient?
- Prednisolone acetate.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prednisolone Acetate?
- 14 other product NDCs are listed under this name. See all Prednisolone Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prednisolone Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| prednisolone acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-2550 | 60219-2550-01 |
| prednisolone acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-2551 | 60219-2551-01 |
| prednisolone acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-2552 | 60219-2552-01 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-7539 | 50090-7539-00 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Redpharm Drug | 67296-2176 | 67296-2176-05 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Lupin Pharmaceuticals, Inc. | 70748-332 | 70748-0332-0270748-0332-0370748-0332-04 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-1912 | 50090-1912-00 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-5275 | 50090-5275-00 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Pacific Pharma, Inc. | 60758-119 | 60758-0119-0560758-0119-1060758-0119-15 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2222 | 68071-2222-05 |
Other NDCs under NDA 017011
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 |
|---|---|---|---|---|
| Pred Forteprednisolone acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Allergan, Inc. | 11980-180 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-1912 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-5275 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Pacific Pharma, Inc. | 60758-119 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2222 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Sportpharm LLC | 85766-124 |