OpusMeds Extra Strength Minoxidil

Product NDC
87338-983
11-digit product format
873380983
Labeler code
87338
Product ID
87338-983_494a6bca-19c5-f856-e063-6294a90ab251
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Opus Meds LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2026-01-06
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OpusMeds Extra Strength Minoxidil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87338-983-00OpusMeds Extra Strength Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION601
87338-983-00OpusMeds Extra Strength Minoxidil1 in 1 BOXSOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNeab00b6d-d49a-4090-8243-ae5e99f6a54e1
311724minoxidil 50 MG/ML Topical SolutionSCDeab00b6d-d49a-4090-8243-ae5e99f6a54e1
311724minoxidil 3 GM per 60 ML Topical SolutionSYeab00b6d-d49a-4090-8243-ae5e99f6a54e1
311724minoxidil 5 % Topical SolutionSYeab00b6d-d49a-4090-8243-ae5e99f6a54e1
311724minoxidil 5 GM per 100 ML Topical SolutionSYeab00b6d-d49a-4090-8243-ae5e99f6a54e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87338-983-00873380983001 BOTTLE, DROPPER in 1 BOX (87338-983-00) / 60 mL in 1 BOTTLE, DROPPER2026-01-06NoNoCurrent