FDA.reportPublic FDA data

Minoxidil

Product NDC
50383-001
11-digit product format
503830001
Labeler code
50383
Product ID
50383-001_32078b63-8b02-4d72-86f2-94e19f055308
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hi-Tech Pharmacal Co., Inc.
Application
ANDA074731
Marketing category
ANDA
Marketing start
1996-12-24
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-001DDiscontinued by firm2026-07-31
excluded productproduct50383-001DDiscontinued by firm2026-07-31
excluded packagepackage50383-00150383-001-02DDiscontinued by firm2026-07-31
excluded packagepackage50383-00150383-001-20DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074731-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-12-24
A074731-002MINOXIDIL (FOR WOMEN)MINOXIDIL2%SOLUTION / TOPICAL2005-05-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074731-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-12-24a50c72e98297…
2026-08-01 22:54:322026-06A074731-002MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2005-05-11a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]4
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RMINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]4
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]2
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-001-02503830001021 BOTTLE in 1 CARTON (50383-001-02) > 60 mL in 1 BOTTLE1 bottle1996-12-240000-00-00NoNoCurrent
50383-001-20503830001201 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE1 bottle1996-12-240000-00-00NoNoCurrent