BOSLEY Minoxidil Topical Solution 5 (for men)

Product NDC
69113-483
11-digit product format
691130483
Labeler code
69113
Product ID
69113-483_1763bf82-0096-5ba2-e063-6394a90acd01
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Scientific Hair Research, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2024-05-06
Substance
MINOXIDIL
Active strength
50 mg/mL
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
BOSLEY Minoxidil Topical Solution 5 (for men)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui1537948

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69113-483-00BOSLEY Minoxidil Topical Solution 5 (for men)1 in 1 BOXLIQUID11
69113-483-00BOSLEY Minoxidil Topical Solution 5 (for men)60 mL in 1 BOTTLELIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69113-483BOSLEY MINOXIDIL TOPICAL SOLUTION 5 (FOR MEN) (MINOXIDIL) LIQUID [SCIENTIFIC HAIR RESEARCH, LLC]1Current NDC, 2 package rows20240507_90d96eb1-a478-42ce-9389-642c57bbf280.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537948minoxidil 5 % Topical SprayPSN90d96eb1-a478-42ce-9389-642c57bbf2801
1537948minoxidil 50 MG/ML Topical SpraySCD90d96eb1-a478-42ce-9389-642c57bbf2801
1537948minoxidil 5 % Topical SpraySY90d96eb1-a478-42ce-9389-642c57bbf2801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69113-483-00691130483001 BOTTLE in 1 BOX (69113-483-00) / 60 mL in 1 BOTTLE1 bottle2024-05-06NoNoHistorical