Fluocinonide NDC 76420-509

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-509Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0509Add 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
76420-509-12	76420050912	1 TUBE in 1 CARTON (76420-509-12) / 120 g in 1 TUBEMarketed from Dec 16, 2023

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): Fluocinonide
Generic name (nonproprietary): fluocinonide
Active ingredients: Fluocinonide — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Asclemed USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200734
Marketing start: Jul 14, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 76420-509_0cad6c91-0fe0-91c8-e063-6394a90a3fe8SPL ID 0cad6c91-0fe0-91c8-e063-6394a90a3fe8SPL set ID cd5d8268-77ff-41c0-8699-b583e52da30cRxCUI 485647UNII 2W4A77YPAN
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

N476420050912 followed by a unit qualifier and the quantity

Package 76420-0509-12. 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 16, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) Avoid use on the face, groin, or axillae. ( 1.2 ) Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200734

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

FDA NDC Directory listings under ANDA 200734
Product	Strength	Form · route	Labeler	Product NDC
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1353