FDA.reportPublic FDA data

ACZONE

Product NDC
0023-3670
11-digit product format
000233670
Labeler code
0023
Product ID
0023-3670_8d6a6d88-5639-4b7b-a712-d0600de69b02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
Allergan, Inc.
Application
NDA021794
Marketing category
NDA
Marketing start
2009-06-24
Substance
DAPSONE
Active strength
50 mg/g
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACZONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui607295, 701858

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae3f83f-9ccb-db71-5718-0b1e959868dfProduct name520260113
5ae2790a-f798-4a69-8811-64a4723c389aProduct name520250325
b8929bfc-0002-d39a-046d-72ddf714efbeProduct name620190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-3670-03ACZONE3 g in 1 TUBEGEL316
0023-3670-03ACZONE15 in 1 CARTONGEL1516
0023-3670-30ACZONE1 in 1 CARTONGEL116
0023-3670-30ACZONE30 g in 1 TUBEGEL3016
0023-3670-60ACZONE1 in 1 CARTONGEL116
0023-3670-60ACZONE60 g in 1 TUBEGEL6016
0023-3670-90ACZONE90 g in 1 TUBEGEL9016
0023-3670-90ACZONE1 in 1 CARTONGEL116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3670-30GM - Gram0023-36708a877d79-2df3-41ff-bb6c-5f7ee8307f8312012-07-24
0023-3670-60GM - Gram0023-367067215fdf-9132-4fcd-85b9-8fdf886a0aa912012-07-24
0023-3670-90GM - Gram0023-36706db28f14-5df6-4b72-800a-5c56832cd94812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dapsoneACTIVE INGREDIENT8W5C518302ACZONE (DAPSONE) GEL [ALLERGAN, INC.]10
dapsoneACTIVE MOIETY8W5C518302ACZONE (DAPSONE) GEL [ALLERGAN, INC.]10
carbomer homopolymer type CINACTIVE INGREDIENT4Q93RCW27EACZONE (DAPSONE) GEL [ALLERGAN, INC.]10
diethylene glycol monoethyl etherINACTIVE INGREDIENTA1A1I8X02BACZONE (DAPSONE) GEL [ALLERGAN, INC.]10
methylparabenINACTIVE INGREDIENTA2I8C7HI9TACZONE (DAPSONE) GEL [ALLERGAN, INC.]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IACZONE (DAPSONE) GEL [ALLERGAN, INC.]10
waterINACTIVE INGREDIENT059QF0KO0RACZONE (DAPSONE) GEL [ALLERGAN, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3670ACZONE (DAPSONE) GEL [ALLERGAN, INC.]15Current NDC, Legacy NDC, 8 package rows20221124_b7d605cf-bf84-461b-939b-1f773a4cba65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
701858Aczone 5 % Topical GelPSNb7d605cf-bf84-461b-939b-1f773a4cba6516
607295dapsone 5 % Topical GelPSNb7d605cf-bf84-461b-939b-1f773a4cba6516
701858dapsone 0.05 MG/MG Topical Gel [Aczone]SBDb7d605cf-bf84-461b-939b-1f773a4cba6516
607295dapsone 0.05 MG/MG Topical GelSCDb7d605cf-bf84-461b-939b-1f773a4cba6516
701858Aczone 0.05 MG/MG Topical GelSYb7d605cf-bf84-461b-939b-1f773a4cba6516
701858Aczone 5 % Topical GelSYb7d605cf-bf84-461b-939b-1f773a4cba6516
607295dapsone 5 % Topical GelSYb7d605cf-bf84-461b-939b-1f773a4cba6516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-3670-030002336700315 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE15 tube2009-06-240000-00-00NoNoCurrent
0023-3670-30000233670301 TUBE in 1 CARTON (0023-3670-30) / 30 g in 1 TUBE1 tube2009-06-240000-00-00NoNoCurrent
0023-3670-60000233670601 TUBE in 1 CARTON (0023-3670-60) / 60 g in 1 TUBE1 tube2009-06-240000-00-00NoNoCurrent
0023-3670-90000233670901 TUBE in 1 CARTON (0023-3670-90) / 90 g in 1 TUBE1 tube2009-06-240000-00-00NoNoCurrent