NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8481Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8481Add 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
63629-8481-1636298481011 TUBE in 1 CARTON (63629-8481-1) / 60 g in 1 TUBEMarketed from Mar 20, 2019

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)
Desonide Ointment, 0.05%
Generic name (nonproprietary)
desonide ointment, 0.05%
Active ingredients
Desonide.5 mg/g
Dosage form
Ointment
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210998
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 63629-8481_5ce2d90b-5c35-44a3-b18b-a245e4d577b1SPL ID 5ce2d90b-5c35-44a3-b18b-a245e4d577b1SPL set ID 1d796425-8fd6-4024-888d-0056627f7190RxCUI 204135UNII J280872D1O
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

N463629848101 followed by a unit qualifier and the quantity

Package 63629-8481-01. 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 Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210998

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

FDA NDC Directory listings under ANDA 210998
ProductStrengthForm · routeLabelerProduct NDC
Desonide Ointment, 0.05%Desonide .5 mg/gOintmentTopicalBryant Ranch Prepack63629-8482
Desonide Ointment, 0.05%Desonide .5 mg/gOintmentTopicalEncube Ethicals, Inc.21922-004
Desonide Ointment, 0.05%Desonide .5 mg/gOintmentTopicalBryant Ranch Prepack72162-1272

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