Home NDC 71335-3120-1 Minoxidil
Product NDC 71335-3120
Requested package NDC 71335-3120-1
11-digit product format 713353120
Labeler code 71335
Product ID 71335-3120_84430a53-9161-415a-bc10-94e2b6df1d62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minoxidil
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 A071345-001 MINOXIDIL 10MG TABLET / ORAL AB RS 1987-03-03 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Minoxidil
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197986 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 71335-3120-1 Minoxidil 100 in 1 BOTTLE TABLET 100 1 71335-3120-2 Minoxidil 30 in 1 BOTTLE TABLET 30 1
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 Sample Exclude flag Status 71335-3120-1 71335312001 100 TABLET in 1 BOTTLE (71335-3120-1) 100 tablet 2026-04-13 No No Current