Prescription drug · NDA AUTHORIZED GENERIC
Prednisolone Acetate NDC 61314-637
Prednisolone acetate 10 mg/mL · Suspension/ drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-637-05 | 61314063705 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Dec 15, 1994 | |
| 61314-637-10 | 61314063710 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from Dec 15, 1994 | |
| 61314-637-15 | 61314063715 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTICMarketed from Dec 15, 1994 |
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
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017469
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7SPL ID 32f12438-f75f-459e-a41f-34dcc8a9e4f7SPL set ID 05d205c7-8f51-46b9-a6c5-4199bc432b26RxCUI 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
N461314063705followed by a unit qualifier and the quantityPackage 61314-0637-05. 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: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Excerpt only. Read the full label for complete information.
About NDC 61314-637
- What is NDC 61314-637?
- 61314-637 is the product NDC for Prednisolone Acetate, Prednisolone acetate 10 mg/mL suspension/ drops, listed with the FDA by Sandoz Inc. It has 3 package NDCs, 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?
- Sandoz Inc, NDC labeler code 61314. 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 | Lupin Pharmaceuticals, Inc. | 70748-332 | 70748-0332-0270748-0332-0370748-0332-04 |
| 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 | Pacific Pharma, Inc. | 60758-119 | 60758-0119-0560758-0119-1060758-0119-15 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | Asclemed USA, Inc. | 76420-204 | 76420-0204-05 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-2222 | 68071-2222-05 |
Other NDCs under NDA 017469
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 | Sportpharm LLC | 85766-258 |
| Prednisolone Acetate | Prednisolone acetate 10 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-0559 |