NDC codes

FDA NDC Directory
Product NDC (as listed)63629-9583Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-9583Add 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
63629-9583-1636299583011 BOTTLE in 1 CARTON (63629-9583-1) / 60 mL in 1 BOTTLEMarketed from Dec 12, 2022

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 topical solution usp, 0.05%
Active ingredients
Fluocinonide — .5 mg/mL
Dosage form
Solution
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209699
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 63629-9583_d174142a-4f0d-4f7b-ab7d-c821590a2361SPL ID d174142a-4f0d-4f7b-ab7d-c821590a2361SPL set ID 38a36184-22b4-4e97-83e1-fdd984ef6ccbRxCUI 310364UNII 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

N463629958301 followed by a unit qualifier and the quantity

Package 63629-9583-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluocinonide topical solution, 0.05% 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 ANDA 209699

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

FDA NDC Directory listings under ANDA 209699
ProductStrengthForm · routeLabelerProduct NDC
Fluocinonidefluocinonide topical solution usp, 0.05%Fluocinonide .5 mg/mLSolutionTopicalNuCare Pharmaceuticals, Inc.68071-3918
Fluocinonidefluocinonide topical solution usp, 0.05%Fluocinonide .5 mg/mLSolutionTopicalEncube Ethicals, Inc.21922-001
Fluocinonidefluocinonide topical solution usp, 0.05%Fluocinonide .5 mg/mLSolutionTopicalBryant Ranch Prepack72162-1270

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