Prescription drug · NDA
Aczone (Dapsone) NDC 16110-526
Dapsone 75 mg/g · Gel · Topical · Almirall, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16110-526-60 | 1611005266016110052660 | 1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMPMarketed from Sep 10, 2019 | |
| 16110-526-90 | 1611005269016110052690 | 1 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
N416110052660followed by a unit qualifier and the quantityPackage 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.
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.