Fluocinonide NDC 63629-2510

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2510Add 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
63629-2510-1	63629251001	30 g in 1 TUBE (63629-2510-1)Marketed from May 18, 2021

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): Fluocinonide
Generic name (nonproprietary): fluocinonide
Active ingredients: Fluocinonide — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208989
Marketing start: Apr 30, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 63629-2510_566bc9f8-66a9-467e-b7e3-49b5dc4ede40SPL ID 566bc9f8-66a9-467e-b7e3-49b5dc4ede40SPL set ID 50d06efd-9caa-4254-bf1f-eb430c5178b0RxCUI 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

N463629251001 followed by a unit qualifier and the quantity

Package 63629-2510-01. 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 Mar 3, 2023.

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 208989

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

FDA NDC Directory listings under ANDA 208989
Product	Strength	Form · route	Labeler	Product NDC
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Viona Pharmaceuticals Inc	72578-087
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Bryant Ranch Prepack	72162-2006
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1393
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Bryant Ranch Prepack	63629-2509
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Bryant Ranch Prepack	63629-2508