Minoxidil

Product NDC: 71205-757
Requested package NDC: 71205-757-30
11-digit product format: 712050757
Labeler code: 71205
Product ID: 71205-757_637718aa-a453-4acd-a992-590d637b63a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minoxidil
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA071344
Marketing category: ANDA
Marketing start: 2009-10-26
Substance: MINOXIDIL
Active strength: 2.5 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
A071344-001	MINOXIDIL	MINOXIDIL	2.5MG	TABLET / ORAL	AB		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
A071344-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071344-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1987-03-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071344-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071344-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071344-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071344-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071344-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071344-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071344-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071344-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071344-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071344-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071344-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071344-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071344-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071344-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071344-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071344-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071344-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071344-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071344-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071344-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071344-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071344-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071344-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071344-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071344-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071344-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071344-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071344-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071344-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071344-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071344-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071344-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071344-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071344-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071344-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071344-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071344-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071344-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071344-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071344-001	AB	1	`f41ea6bd6efb…`

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	2.5 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
197987	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
637718aa-a453-4acd-a992-590d637b63a3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-757-30	Minoxidil	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
71205-757-60	Minoxidil	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
71205-757-90	Minoxidil	90 in 1 BOTTLE, PLASTIC	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-757	MINOXIDIL TABLET [PROFICIENT RX LP]	1	Current NDC, 3 package rows	20230211_637718aa-a453-4acd-a992-590d637b63a3.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	8ccd07ab-07ed-4b42-b182-3d22b98abca7	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071344 application number: ANDA071344
Minoxidil	MINOXIDIL	Actavis Pharma, Inc.	ab30461c-f8c8-409d-9e24-d58ed8a34873	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071344 application number: ANDA071344
Minoxidil	MINOXIDIL	Proficient Rx LP	637718aa-a453-4acd-a992-590d637b63a3	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071344 application number: ANDA071344 ndc (package): 71205-757-30 ndc (product): 71205-757 ndc11 (package): 71205075730

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5965120SH1	MINOXIDIL	38304-91-5	MINOXIDIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197987	minoxidil 2.5 MG Oral Tablet	PSN	637718aa-a453-4acd-a992-590d637b63a3	1
197987	minoxidil 2.5 MG Oral Tablet	SCD	637718aa-a453-4acd-a992-590d637b63a3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71205-757-30	71205075730	30 TABLET in 1 BOTTLE, PLASTIC (71205-757-30)	30 tablet	2023-02-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Tablets USP Revised: March 2016 Rx Only	Proficient Rx LP	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	1