NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0418Add 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
80425-0418-180425041801804250418011 TUBE in 1 CARTON (80425-0418-1) / 60 g in 1 TUBEMarketed from Jul 17, 2024

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
Generic name (nonproprietary)
desonide
Active ingredients
Desonide — .5 mg/g
Dosage form
Cream
Route
Topical
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074027
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 80425-0418_1d76541f-80d7-2a55-e063-6294a90aa5f9SPL ID 1d76541f-80d7-2a55-e063-6294a90aa5f9SPL set ID 1d7632a7-0f27-9e5d-e063-6294a90ad21fRxCUI 349351UNII 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

N480425041801 followed by a unit qualifier and the quantity

Package 80425-0418-01. 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 Cream, 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)

About NDC 80425-0418

What is NDC 80425-0418?
80425-0418 is the product NDC for Desonide, Desonide .5 mg/g cream, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Desonide.
What is the active ingredient?
Desonide.
Who is the labeler?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Desonide?
23 other product NDCs are listed under this name. See all Desonide NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Desonide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DesonideDesonide .5 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-63246708-0632-1546708-0632-60
DesonideDesonide .5 mg/mLLotionTopicalAlembic Pharmaceuticals Limited46708-55046708-0550-1846708-0550-59
DesonideDesonide .5 mg/gOintmentTopicalAlembic Pharmaceuticals Limited46708-48546708-0485-1546708-0485-60
DesonideDesonide .5 mg/gCreamTopicalAdvanced Rx of Tennessee, LLC80425-037180425-0371-01
DesonideDesonide .5 mg/gOintmentTopicalNORTHSTAR RX LLC72603-16472603-0164-0172603-0164-02
DesonideDesonide .5 mg/gCreamTopicalAlembic Pharmaceuticals Inc.62332-63262332-0632-1562332-0632-60
DesonideDesonide .5 mg/mLLotionTopicalAlembic Pharmaceuticals Inc.62332-55062332-0550-1862332-0550-59
DesonideDesonide .5 mg/gGelTopicalCintex Services, LLC24470-92024470-0920-60
DesonideDesonide .5 mg/gCreamTopicalBryant Ranch Prepack63629-250663629-2506-01
DesonideDesonide .5 mg/gCreamTopicalBryant Ranch Prepack63629-250763629-2507-01

All 24 Desonide NDCs

Other NDCs under ANDA 074027

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

FDA NDC Directory listings under ANDA 074027
ProductStrengthForm · routeLabelerProduct NDC
DesonideDesonide .5 mg/gCreamTopicalCosette Pharmaceuticals, Inc.0713-0661

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