NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2222Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2222Add 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
68071-2222-5680712222051 BOTTLE, DROPPER in 1 CARTON (68071-2222-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jul 27, 2020

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
NDA authorized genericApplication NDA 017011
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 68071-2222_1d7617a8-dae4-7892-e063-6294a90a3f9fSPL ID 1d7617a8-dae4-7892-e063-6294a90a3f9fSPL set ID ab72cf3d-7660-41b1-e053-2995a90a7f44RxCUI 1376336UNII 8B2807733DUPC 0368071222258
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

N468071222205 followed by a unit qualifier and the quantity

Package 68071-2222-05. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017011

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

FDA NDC Directory listings under NDA 017011
ProductStrengthForm · routeLabelerProduct NDC
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicAsclemed USA, Inc.76420-204
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicA-S Medication Solutions50090-1912
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicA-S Medication Solutions50090-5275
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicSportpharm LLC85766-124
Prednisolone AcetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicPacific Pharma, Inc.60758-119
Pred Forteprednisolone acetatePrednisolone acetate 10 mg/mLSuspension/ dropsOphthalmicAllergan, Inc.11980-180

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