Home NDC 0591-5643 Minoxidil
Product NDC 0591-5643
11-digit product format 005915643
Labeler code 0591
Product ID 0591-5643_d5ec5f1a-1c30-44a8-93f5-e9e9feef03e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minoxidil
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA071345
Marketing category ANDA
Marketing start 2009-10-26
Substance MINOXIDIL
Active strength 10 mg/1
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-5643 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0591-5643 0591-5643-00 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0591-5643 0591-5643-77 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A071345-001 MINOXIDIL MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071345-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Minoxidil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197986 Internal RxNorm lookup 197987 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-5643-01 Minoxidil 100 in 1 BOTTLE, PLASTIC TABLET 100 10 0591-5643-05 Minoxidil 500 in 1 BOTTLE, PLASTIC TABLET 500 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOXIDIL ACTIVE INGREDIENT 5965120SH1 MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MINOXIDIL ACTIVE INGREDIENT 5965120SH1 MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 MINOXIDIL ACTIVE MOIETY 5965120SH1 MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MINOXIDIL ACTIVE MOIETY 5965120SH1 MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MINOXIDIL TABLET [WATSON LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5643 MINOXIDIL TABLET [ACTAVIS PHARMA, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250228_ab30461c-f8c8-409d-9e24-d58ed8a34873.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-5643-00 00591564300 91000 TABLET in 1 BAG (0591-5643-00) 91000 tablet 26-OCT-09 Current 0591-5643-01 00591564301 100 TABLET in 1 BOTTLE, PLASTIC (0591-5643-01) 100 tablet 2009-10-26 0000-00-00 No No Current 0591-5643-05 00591564305 500 TABLET in 1 BOTTLE, PLASTIC (0591-5643-05) 500 tablet 2009-10-26 0000-00-00 No No Current 0591-5643-77 00591564377 109092 TABLET in 1 CONTAINER (0591-5643-77) 109092 tablet 11-JUN-24 Current