Home NDC 68016-006-64 Minoxidil
Product NDC 68016-006
Requested package NDC 68016-006-64
11-digit product format 680160006
Labeler code 68016
Product ID 68016-006_45b26231-d780-490d-b50d-fac294807c87
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Chain Drug Consortium, LLC
Application ANDA074588
Marketing category ANDA
Marketing start 2000-01-01
Marketing end 0000-00-00
Substance MINOXIDIL
Active strength 2 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 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 · 7 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074588-001 MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION / TOPICAL 1996-04-05
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074588-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1996-04-05 cb3db0bc1861…
DailyMed Socrata Ingredients# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68016-006-64 68016000664 2 BOTTLE, DROPPER in 1 CARTON (68016-006-64) > 60 mL in 1 BOTTLE, DROPPER 2000-01-01 0000-00-00 No No Current