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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219015-001	EMROSI	MINOCYCLINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2024-11-01

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N219015-001	10905664	2039-01-07	U-4043	2024-11-25
N219015-001	11191740	2039-01-07	U-4043	2024-11-25
N219015-001	11364212	2039-01-07	U-4043	2024-11-25
N219015-001	12594252	2039-01-07	U-4043	2026-04-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219015-001	NP	2027-11-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	12594252	2039-01-07	U-4043	2026-04-16	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219015-001	NP	2027-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	NP	2027-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219015-001	NP	2027-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	NP	2027-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	NP	2027-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	NP	2027-11-01	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	NP	2027-11-01	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0020414E5U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2706371	Internal RxNorm lookup
2706378	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0899eb25-8807-037c-f66c-141a2696b1c0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7	Product name	1	20250623
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92	Product name	2	20230322
472a6924-c7ed-850b-32ce-a510e887fbf9	Product name	4	20230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55d	Product name	1	20201103
7a57513a-a145-4b95-9165-1e0ef21d6017	Product name	1	20200326
70555e58-6951-4421-9354-f80c6ce0d92c	Product name	7	20200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4ef	Product name	5	20180605
76736e48-254d-4a39-993d-206efbdaad1d	Product name	1	20170717
0c498039-5512-d9d7-e6b6-833de47219ff	Product name	2	20151106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69489-131-07	EMROSI	7 in 1 BOTTLE	CAPSULE	7		5
69489-131-30	EMROSI	30 in 1 BOTTLE	CAPSULE	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69489-131-30	EA - Each	69489-131	840d59da-3431-4f62-b8e4-82bc21089323	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69489-131	EMROSI (MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE) CAPSULE [JOURNEY MEDICAL CORPORATION]	5	Current NDC, 2 package rows	20250424_0899eb25-8807-037c-f66c-141a2696b1c0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EMROSI	MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE	Journey Medical Corporation	0899eb25-8807-037c-f66c-141a2696b1c0	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219015 application number: NDA219015 ndc (product): 69489-131

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0020414E5U	MINOCYCLINE HYDROCHLORIDE	13614-98-7	MINOCYCLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2706378	emrosi 40 MG 24HR Extended Release Oral Capsule	PSN	0899eb25-8807-037c-f66c-141a2696b1c0	5
2706371	minocycline 40 MG 24 HR Extended Release Oral Capsule	PSN	0899eb25-8807-037c-f66c-141a2696b1c0	5
2706378	24 HR minocycline 40 MG Extended Release Oral Capsule [Emrosi]	SBD	0899eb25-8807-037c-f66c-141a2696b1c0	5
2706371	24 HR minocycline 40 MG Extended Release Oral Capsule	SCD	0899eb25-8807-037c-f66c-141a2696b1c0	5
2706378	24 HR Emrosi 40 MG (as minocycline hydrochloride) Extended Release Oral Capsule	SY	0899eb25-8807-037c-f66c-141a2696b1c0	5
2706371	24 HR minocycline 40 MG (as minocycline hydrochloride) Extended Release Oral Capsule	SY	0899eb25-8807-037c-f66c-141a2696b1c0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69489-131-07	69489013107	7 CAPSULE in 1 BOTTLE (69489-131-07)	7 capsule	2025-03-10	No	No	Current
69489-131-30	69489013130	30 CAPSULE in 1 BOTTLE (69489-131-30)	30 capsule	2025-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EMROSI	Journey Medical Corporation \| Dr. Reddy’s Laboratories Limited \| Dr. Reddy’s Laboratories Limited-FTO SEZ PU-1	2025-04-22	HUMAN PRESCRIPTION DRUG LABEL	5