NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7539Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7539Add 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 NDC11-digit (billing)PackageCopy
50090-7539-0500907539001 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
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

N450090753900 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216935

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

FDA NDC Directory listings under ANDA 216935
ProductStrengthForm · routeLabelerProduct NDC
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicLupin Pharmaceuticals, Inc.70748-332
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicRedpharm Drug67296-2176

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