Minoxidil

Product NDC
61269-094
11-digit product format
612690094
Labeler code
61269
Product ID
61269-094_4162d466-6dd6-406e-ba78-253eb04f394b
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
H2-Pharma, LLC
Application
ANDA075518
Marketing category
ANDA
Marketing start
2022-04-25
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-094-73ML - Milliliter61269-09434fdfb1d-8fb7-487a-80ef-e0b71df5c20712022-05-04
61269-094-75ML - Milliliter61269-094714c4010-70ff-4e95-a90a-034510ca8eea12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-094MINOXIDIL SOLUTION [H2-PHARMA, LLC]2Legacy NDC20250101_f33502d3-e330-48d1-a38e-b98cf0b14b61.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61269-094-73612690094731 BOTTLE, DROPPER in 1 CARTON (61269-094-73) > 60 mL in 1 BOTTLE, DROPPER2022-04-250000-00-00NoNoCurrent
61269-094-75612690094752 BOTTLE, DROPPER in 1 CARTON (61269-094-75) > 60 mL in 1 BOTTLE, DROPPER2022-04-250000-00-00NoNoCurrent