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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212379-001AMZEEQMINOCYCLINE HYDROCHLORIDEEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212379-001100860802030-10-01U-26472019-11-15
N212379-001101372002030-10-01U-26472019-11-15
N212379-001102135122030-10-01U-2647Drug product2019-11-15
N212379-001102654042030-10-01Drug product2019-11-15
N212379-001105178822030-10-01U-26472020-01-10
N212379-001108211872030-10-01U-26472020-11-16
N212379-00188651392030-10-01U-2647Drug product2019-11-15
N212379-00189455162030-10-01Drug product2019-11-15
N212379-00189928962030-10-01U-2647Drug product2019-11-15
N212379-00196757002030-10-01U-2647Drug product2019-11-15
N212379-001103986412037-09-08U-26472019-11-15
N212379-001108498472037-09-08U-26472020-12-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-183f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212379-001AMZEEQEQ 4% BASEAEROSOL, FOAM / TOPICALRLD, RS2019-10-18a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 12 · 451 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212379-001100860802030-10-01U-26472019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001101372002030-10-01U-26472019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001102135122030-10-01U-2647Drug product2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001102654042030-10-01Drug product2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001105178822030-10-01U-26472020-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001108211872030-10-01U-26472020-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-00188651392030-10-01U-2647Drug product2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-00189455162030-10-01Drug product2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-00189928962030-10-01U-2647Drug product2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-00196757002030-10-01U-2647Drug product2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001103986412037-09-08U-26472019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212379-001108498472037-09-08U-26472020-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001100860802030-10-01U-26472019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001101372002030-10-01U-26472019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001102135122030-10-01U-2647Drug product2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001102654042030-10-01Drug product2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001105178822030-10-01U-26472020-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001108211872030-10-01U-26472020-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-00188651392030-10-01U-2647Drug product2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-00189455162030-10-01Drug product2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-00189928962030-10-01U-2647Drug product2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-00196757002030-10-01U-2647Drug product2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001103986412037-09-08U-26472019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212379-001108498472037-09-08U-26472020-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N212379-001100860802030-10-01U-26472019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001101372002030-10-01U-26472019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001102135122030-10-01U-2647Drug product2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001102654042030-10-01Drug product2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001105178822030-10-01U-26472020-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001108211872030-10-01U-26472020-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-00188651392030-10-01U-2647Drug product2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-00189455162030-10-01Drug product2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-00189928962030-10-01U-2647Drug product2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-00196757002030-10-01U-2647Drug product2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001103986412037-09-08U-26472019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212379-001108498472037-09-08U-26472020-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212379-001100860802030-10-01U-26472019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212379-001101372002030-10-01U-26472019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212379-001102135122030-10-01U-2647Drug product2019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212379-001102654042030-10-01Drug product2019-11-15fd3edfee7708…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0020414E5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2257673Internal RxNorm lookup
2257678Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc251492-977b-4eb1-a088-a90831324badAvailable on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMZEEQMINOCYCLINEJourney Medical Corporationcc251492-977b-4eb1-a088-a90831324bad2023-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 212379
application number: NDA212379
ndc (product): 69489-201

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