Fluocinolone Acetonide Topical NDC 0591-2990

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2990Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2990Add 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
0591-2990-60	00591299060	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATORMarketed from Dec 7, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Topical
Generic name (nonproprietary): fluocinolone acetonide topical
Active ingredients: Fluocinolone acetonide — .1 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208386
Marketing start: Dec 7, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800SPL ID 8c1b96a1-47e6-4fac-9bda-0b299ac25800SPL set ID 98dfd7a4-2208-4637-acf5-080a5813a433RxCUI 1191310UNII 0CD5FD6S2M
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

N400591299060 followed by a unit qualifier and the quantity

Package 00591-2990-60. 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 Aug 1, 2016.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)