Home NDC 72789-279 MINOXIDIL
Product NDC 72789-279
11-digit product format 727890279
Labeler code 72789
Product ID 72789-279_2c24f826-a63a-f1e1-e063-6394a90a5909
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name minoxidil
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA072709
Marketing category ANDA
Marketing start 1995-12-14
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072709-001 MINOXIDIL MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 A072709-002 MINOXIDIL MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072709-001 MINOXIDIL 10MG TABLET / ORAL AB 1995-12-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A072709-002 MINOXIDIL 2.5MG TABLET / ORAL AB 1995-12-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 72789-279-01 MINOXIDIL 100 in 1 BOTTLE, PLASTIC TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-279 MINOXIDIL TABLET [PD-RX PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20250121_f0dae476-8d0b-4d0c-a505-ad51bf27a1c8.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MINOXIDIL MINOXIDIL PD-Rx Pharmaceuticals, Inc. 5fea137a-bc88-4b24-85db-538c90ad1870 2026-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072709 application number: ANDA072709 MINOXIDIL MINOXIDIL PD-Rx Pharmaceuticals, Inc. f0dae476-8d0b-4d0c-a505-ad51bf27a1c8 2026-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072709 application number: ANDA072709 ndc (product): 72789-279 MINOXIDIL MINOXIDIL Sun Pharmaceutical Industries, Inc. 0354a7f5-5917-44dc-9963-411104008cb5 2026-02-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072709 application number: ANDA072709 MINOXIDIL MINOXIDIL Bryant Ranch Prepack 40da3ec5-39db-42f1-b0d6-39d852130307 2024-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072709 application number: ANDA072709
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 72789-279-01 72789027901 100 TABLET in 1 BOTTLE, PLASTIC (72789-279-01) 100 tablet 2022-10-07 0000-00-00 No No Current