Prednisolone Acetate NDC 61314-637

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-637Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0637Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
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 Inc
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 017469
Marketing start: Dec 15, 1994
Listing expires: Dec 31, 2026
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

N461314063705 followed by a unit qualifier and the quantity

Package 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 Dec 30, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017469

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 017469
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