Home NDC 50383-001-20 Minoxidil
Product NDC 50383-001
Requested package NDC 50383-001-20
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074731-001 MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION / TOPICAL 1996-12-24 A074731-002 MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION / TOPICAL 2005-05-11
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.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074731-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-12-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074731-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 2005-05-11 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOXIDIL ACTIVE INGREDIENT 5965120SH1 MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 4 MINOXIDIL ACTIVE MOIETY 5965120SH1 MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 4 MINOXIDIL ACTIVE INGREDIENT 5965120SH1 MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 MINOXIDIL ACTIVE MOIETY 5965120SH1 MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-001-20 50383000120 1 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE 1 bottle 1996-12-24 0000-00-00 No No Current