bourn Hair Regrowth Treatment for Men

Product NDC
81553-001
11-digit product format
815530001
Labeler code
81553
Product ID
81553-001_f1e96fe0-0675-26a8-e053-2a95a90ae60b
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 5%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Octri, Inc.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2021-02-04
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
5 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81553-001-012025-01-30C16284748780-12cef2736-641c-d83d-e063-dadaa90ab31fbourn Minoxidil Topical Solution, USP 5% - Hair Regrowth Treatment for Men

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81553-001-01bourn Hair Regrowth Treatment for Men6 in 1 BOXSOLUTION63
81553-001-01bourn Hair Regrowth Treatment for Men60 mL in 1 BOTTLESOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81553-001BOURN HAIR REGROWTH TREATMENT FOR MEN (MINOXIDIL 5%) SOLUTION [OCTRI, INC.]3Legacy NDC, 2 package rows20230111_ba8ada1b-f362-4ec8-e053-2995a90a575a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNba8ada1b-f362-4ec8-e053-2995a90a575a3
311724minoxidil 50 MG/ML Topical SolutionSCDba8ada1b-f362-4ec8-e053-2995a90a575a3
311724minoxidil 3 GM per 60 ML Topical SolutionSYba8ada1b-f362-4ec8-e053-2995a90a575a3
311724minoxidil 5 % Topical SolutionSYba8ada1b-f362-4ec8-e053-2995a90a575a3
311724minoxidil 5 GM per 100 ML Topical SolutionSYba8ada1b-f362-4ec8-e053-2995a90a575a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81553-001-01815530001016 BOTTLE in 1 BOX (81553-001-01) > 60 mL in 1 BOTTLE6 bottle2021-02-040000-00-00NoNoCurrent