FDA.reportPublic FDA data

ZILXI

Product NDC
69489-212
11-digit product format
694890212
Labeler code
69489
Product ID
69489-212_e5d4b4fa-1951-4fa8-9677-acb97b10c087
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Journey Medical Corporation
Application
NDA213690
Marketing category
NDA
Marketing start
2022-10-01
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
15 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
ZILXI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE15 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui2375333, 2375338

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69489-212-03ZILXI3 g in 1 CANAEROSOL, FOAM33
69489-212-03ZILXI1 in 1 CARTONAEROSOL, FOAM13
69489-212-07ZILXI1 in 1 CARTONAEROSOL, FOAM13
69489-212-07ZILXI7 g in 1 CANAEROSOL, FOAM73
69489-212-30ZILXI30 g in 1 CANAEROSOL, FOAM303
69489-212-30ZILXI1 in 1 CARTONAEROSOL, FOAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69489-212-30GM - Gram69489-212b4596aa8-9193-4e65-82df-3278b8e5ee8712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69489-212ZILXI (MINOCYCLINE) AEROSOL, FOAM [JOURNEY MEDICAL CORPORATION]3Current NDC, Legacy NDC, 6 package rows20240210_cbffa96e-2446-43cf-ba5e-38c645302afd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2375333minocycline 1.5 % Topical FoamPSNcbffa96e-2446-43cf-ba5e-38c645302afd3
2375338ZILXI 1.5 % Topical FoamPSNcbffa96e-2446-43cf-ba5e-38c645302afd3
2375338minocycline 15 MG/ML Topical Foam [Zilxi]SBDcbffa96e-2446-43cf-ba5e-38c645302afd3
2375333minocycline 15 MG/ML Topical FoamSCDcbffa96e-2446-43cf-ba5e-38c645302afd3
2375333minocycline 1.5 % Topical FoamSYcbffa96e-2446-43cf-ba5e-38c645302afd3
2375338Zilxi 1.5 % Topical FoamSYcbffa96e-2446-43cf-ba5e-38c645302afd3
2375338Zilxi 15 MG/ML Topical FoamSYcbffa96e-2446-43cf-ba5e-38c645302afd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69489-212-03694890212031 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN1 can2023-11-01YesNoCurrent
69489-212-07694890212071 CAN in 1 CARTON (69489-212-07) > 7 g in 1 CAN1 can2022-10-010000-00-00YesNoCurrent
69489-212-30694890212301 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CAN1 can2023-06-01NoNoCurrent