fluocinolone acetonide NDC 62559-289

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-289Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0289Add 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	Copy
62559-289-15	62559028915	1 TUBE in 1 CARTON (62559-289-15) / 15 g in 1 TUBEMarketed from May 8, 2024
62559-289-60	62559028960	1 TUBE in 1 CARTON (62559-289-60) / 60 g in 1 TUBEMarketed from May 8, 2024

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): fluocinolone acetonide
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .25 mg/g
Dosage form: Cream
Route: Topical
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 012787
Marketing start: May 8, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 62559-289_9a3159b1-5a5c-4784-8f61-a132de5c4608SPL ID 9a3159b1-5a5c-4784-8f61-a132de5c4608SPL set ID 50e7006d-a51b-49aa-8e1c-330340e7bf82RxCUI 1191302, 1191315UNII 0CD5FD6S2MUPC 0362559288156, 0362559289153
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462559028915 followed by a unit qualifier and the quantity

Package 62559-0289-15. 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 Feb 23, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 012787

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

FDA NDC Directory listings under NDA 012787
Product	Strength	Form · route	Labeler	Product NDC
fluocinolone acetonide	Fluocinolone acetonide .1 mg/g	CreamTopical	ANI Pharmaceuticals, Inc.	62559-288
Synalarfluocinolone acetonide	Fluocinolone acetonide .25 mg/g	CreamTopical	Medimetriks Pharmaceuticals, Inc.	43538-900