Regen

Product NDC
70788-580
11-digit product format
707880580
Labeler code
70788
Product ID
70788-580_ab7844b9-fc1f-40da-9992-2c6eda824ee3
Type
HUMAN OTC DRUG
Nonproprietary name
5% Minoxidil Topical Solution
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Premium Distribution, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
50 mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70788-580-012020-01-31C16284748780-19d75b9d0-29e0-f424-e053-dadaa90a57cebffed457-967a-4afb-87c9-3e4e1285f04d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70788-580-01Regen60 mL in 1 BOTTLE, PLASTICSOLUTION601
70788-580-01Regen1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70788-580REGEN (5% MINOXIDIL TOPICAL SOLUTION) SOLUTION [PREMIUM DISTRIBUTION, LLC]1Legacy NDC, 2 package rows20170428_bffed457-967a-4afb-87c9-3e4e1285f04d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNbffed457-967a-4afb-87c9-3e4e1285f04d1
311724minoxidil 50 MG/ML Topical SolutionSCDbffed457-967a-4afb-87c9-3e4e1285f04d1
311724minoxidil 3 GM per 60 ML Topical SolutionSYbffed457-967a-4afb-87c9-3e4e1285f04d1
311724minoxidil 5 % Topical SolutionSYbffed457-967a-4afb-87c9-3e4e1285f04d1
311724minoxidil 5 GM per 100 ML Topical SolutionSYbffed457-967a-4afb-87c9-3e4e1285f04d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70788-580-017078805800160 mL in 1 BOTTLE, PLASTIC60 mlHistorical