NDC codes

FDA NDC Directory
Product NDC (as listed)16110-526Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16110-0526Add 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
16110-526-6016110052660161100526601 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMPMarketed from Sep 10, 2019
16110-526-9016110052690161100526901 BOTTLE, PUMP in 1 CARTON (16110-526-90) / 90 g in 1 BOTTLE, PUMPMarketed from Sep 10, 2019

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)
Aczone
Generic name (nonproprietary)
dapsone
Active ingredients
Dapsone — 75 mg/g
Dosage form
Gel
Route
Topical
Labeler
Almirall, LLCNDC labeler code 16110
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 207154
Marketing start
Listing expires
Other FDA classes
Sulfones (Chemical structure)
Identifiers
Product ID 16110-526_fee319ef-b2af-415e-8e91-32aaccc024daSPL ID fee319ef-b2af-415e-8e91-32aaccc024daSPL set ID 22058b7d-a578-4eaa-a476-ac982337f02aRxCUI 1741905, 1741907UNII 8W5C518302
Pharmacologic class
Sulfone

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

N416110052660 followed by a unit qualifier and the quantity

Package 16110-0526-60. 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)

ACZONE ® (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ACZONE ® Gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16110-526

What is NDC 16110-526?
16110-526 is the product NDC for Aczone (dapsone), Dapsone 75 mg/g gel, listed with the FDA by Almirall, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aczone (Dapsone).
What is the active ingredient?
Dapsone.
Who is the labeler?
Almirall, LLC, NDC labeler code 16110. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aczone?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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