FDA.reportPublic FDA data

Minoxidil

Product NDC
11673-158
11-digit product format
116730158
Labeler code
11673
Product ID
11673-158_163b27c3-d12e-e049-e063-6294a90a165c
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
TARGET Corporation
Application
ANDA209074
Marketing category
ANDA
Marketing start
2022-08-16
Substance
MINOXIDIL
Active strength
50 mg/g
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil
Brand name suffix
(For Women)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui645146

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-158-042024-04-16C16284748780-11030e365-0d0a-111a-e063-dadaa90a10e2Minoxidil 5% (For Women)
11673-158-082024-04-16C16284748780-11030e365-0d0a-111a-e063-dadaa90a10e2Minoxidil 5% (For Women)
11673-158-042024-01-30C16284748780-11030e365-0d0a-111a-e063-dadaa90a10e2Minoxidil 5% (For Women)
11673-158-082024-01-30C16284748780-11030e365-0d0a-111a-e063-dadaa90a10e2Minoxidil 5% (For Women)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-158-04Minoxidil (For Women)1 in 1 CARTONAEROSOL, FOAM13
11673-158-04Minoxidil (For Women)60 g in 1 CANAEROSOL, FOAM603
11673-158-08Minoxidil (For Women)60 g in 1 CANAEROSOL, FOAM603
11673-158-08Minoxidil (For Women)2 in 1 CARTONAEROSOL, FOAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-158MINOXIDIL (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [TARGET CORPORATION]3Current NDC, Legacy NDC, 4 package rows20240418_3a6bef39-1d8e-4ce3-9484-becd294566da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSN3a6bef39-1d8e-4ce3-9484-becd294566da3
645146minoxidil 50 MG/ML Topical FoamSCD3a6bef39-1d8e-4ce3-9484-becd294566da3
645146minoxidil 5 % Topical FoamSY3a6bef39-1d8e-4ce3-9484-becd294566da3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-158-04116730158041 CAN in 1 CARTON (11673-158-04) / 60 g in 1 CAN1 can2022-08-160000-00-00NoNoCurrent
11673-158-08116730158082 CAN in 1 CARTON (11673-158-08) / 60 g in 1 CAN2 can2022-08-160000-00-00NoNoCurrent