NDC 16110-526

Aczone

Dapsone

Aczone is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Dapsone.

• Product ID: 16110-526_6655b5f4-f3b7-11eb-85b4-0800200c9a66
• NDC: 16110-526
• Product Type: Human Prescription Drug
• Proprietary Name: Aczone
• Generic Name: Dapsone
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-09-10
• Marketing Category: NDA / NDA
• Application Number: NDA207154
• Labeler Name: Almirall, LLC
• Substance Name: DAPSONE
• Active Ingredient Strength: 75 mg/g
• Pharm Classes: Sulfone [EPC],Sulfones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 16110-526-30

1 BOTTLE, PUMP in 1 CARTON (16110-526-30) > 30 g in 1 BOTTLE, PUMP

• Marketing Start Date: 2019-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-526-30 [16110052630]

Aczone GEL

• Marketing Category: NDA
• Application Number: NDA207154
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-10

NDC 16110-526-90 [16110052690]

Aczone GEL

• Marketing Category: NDA
• Application Number: NDA207154
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-10

NDC 16110-526-60 [16110052660]

Aczone GEL

• Marketing Category: NDA
• Application Number: NDA207154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-09-10

Drug Details

Active Ingredients

Ingredient	Strength
DAPSONE	75 mg/g

OpenFDA Data

• SPL SET ID: 22058b7d-a578-4eaa-a476-ac982337f02a
• Manufacturer:
  • Almirall, LLC
• UNII:
  • 8W5C518302
• RxNorm Concept Unique ID - RxCUI:
  • 1741905
  • 1741907
• UPC Code:
  • 0316110526904
  • 0316110526607

Pharmacological Class

• Sulfone [EPC]
• Sulfones [CS]
• Sulfone [EPC]
• Sulfones [CS]

NDC Crossover Matching brand name "Aczone" or generic name "Dapsone"

NDC	Brand Name	Generic Name
0023-3670	ACZONE	dapsone
0023-5206	ACZONE	dapsone
16110-367	ACZONE	dapsone
16110-526	Aczone	dapsone
0378-4830	Dapsone	Dapsone
0904-7018	DAPSONE	Dapsone
0904-7019	DAPSONE	Dapsone
10135-654	DAPSONE	Dapsone
10135-655	DAPSONE	Dapsone
13668-605	dapsone	dapsone
13925-504	Dapsone	Dapsone
13925-505	Dapsone	Dapsone
16714-956	Dapsone	Dapsone
29033-036	Dapsone	Dapsone
29033-037	Dapsone	Dapsone
42291-298	Dapsone	Dapsone
42291-299	Dapsone	Dapsone
43353-222	Dapsone	Dapsone
43353-223	Dapsone	Dapsone
47781-333	Dapsone	dapsone
47781-334	Dapsone	dapsone
49938-101	Dapsone	Dapsone
49938-102	Dapsone	Dapsone
51672-1387	Dapsone	Dapsone
51672-1388	Dapsone	Dapsone
51672-4197	Dapsone	Dapsone