FDA.reportPublic FDA data

AMZEEQ

Product NDC
69489-201
11-digit product format
694890201
Labeler code
69489
Product ID
69489-201_28ee8ff9-b982-4e9d-e063-6294a90a900c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Journey Medical Corporation
Application
NDA212379
Marketing category
NDA
Marketing start
2022-03-25
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
40 mg/g
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui2257673, 2257678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55dProduct name120201103
7a57513a-a145-4b95-9165-1e0ef21d6017Product name120200326
70555e58-6951-4421-9354-f80c6ce0d92cProduct name720200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69489-201-03AMZEEQ1 in 1 CARTONAEROSOL, FOAM13
69489-201-03AMZEEQ3 g in 1 CANAEROSOL, FOAM33
69489-201-30AMZEEQ1 in 1 CARTONAEROSOL, FOAM13
69489-201-30AMZEEQ30 g in 1 CANAEROSOL, FOAM303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69489-201-30GM - Gram69489-201046a8d29-4ac2-4f18-91e2-7e28a32d402212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69489-201AMZEEQ (MINOCYCLINE) AEROSOL, FOAM [JOURNEY MEDICAL CORPORATION]3Current NDC, Legacy NDC, 4 package rows20241212_cc251492-977b-4eb1-a088-a90831324bad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2257678amzeeq 4 % Topical FoamPSNcc251492-977b-4eb1-a088-a90831324bad3
2257673minocycline 4 % Topical FoamPSNcc251492-977b-4eb1-a088-a90831324bad3
2257678minocycline 40 MG/ML Topical Foam [Amzeeq]SBDcc251492-977b-4eb1-a088-a90831324bad3
2257673minocycline 40 MG/ML Topical FoamSCDcc251492-977b-4eb1-a088-a90831324bad3
2257678Amzeeq (as minocycline HCl) 4 % Topical FoamSYcc251492-977b-4eb1-a088-a90831324bad3
2257673minocycline (as minocycline HCl) 4 % Topical FoamSYcc251492-977b-4eb1-a088-a90831324bad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69489-201-03694890201031 CAN in 1 CARTON (69489-201-03) / 3 g in 1 CAN1 can2023-01-25YesNoCurrent
69489-201-30694890201301 CAN in 1 CARTON (69489-201-30) / 30 g in 1 CAN1 can2022-03-250000-00-00NoNoCurrent