EMROSI

Product NDC
69489-131
11-digit product format
694890131
Labeler code
69489
Product ID
69489-131_335d912c-9d84-1e78-e063-6294a90aa2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride Extended-Release
Dosage form
CAPSULE
Route
ORAL
Labeler
Journey Medical Corporation
Application
NDA219015
Marketing category
NDA
Marketing start
2025-03-01
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
40 mg/1
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
EMROSI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui2706371, 2706378

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69489-131-07EMROSI7 in 1 BOTTLECAPSULE75
69489-131-30EMROSI30 in 1 BOTTLECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69489-131EMROSI (MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE) CAPSULE [JOURNEY MEDICAL CORPORATION]5Current NDC, 2 package rows20250424_0899eb25-8807-037c-f66c-141a2696b1c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2706378emrosi 40 MG 24HR Extended Release Oral CapsulePSN0899eb25-8807-037c-f66c-141a2696b1c05
2706371minocycline 40 MG 24 HR Extended Release Oral CapsulePSN0899eb25-8807-037c-f66c-141a2696b1c05
270637824 HR minocycline 40 MG Extended Release Oral Capsule [Emrosi]SBD0899eb25-8807-037c-f66c-141a2696b1c05
270637124 HR minocycline 40 MG Extended Release Oral CapsuleSCD0899eb25-8807-037c-f66c-141a2696b1c05
270637824 HR Emrosi 40 MG (as minocycline hydrochloride) Extended Release Oral CapsuleSY0899eb25-8807-037c-f66c-141a2696b1c05
270637124 HR minocycline 40 MG (as minocycline hydrochloride) Extended Release Oral CapsuleSY0899eb25-8807-037c-f66c-141a2696b1c05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69489-131-07694890131077 CAPSULE in 1 BOTTLE (69489-131-07) 7 capsule2025-03-10NoNoCurrent
69489-131-306948901313030 CAPSULE in 1 BOTTLE (69489-131-30) 30 capsule2025-03-01NoNoCurrent