MINOXIDIL

Product NDC: 42291-619
11-digit product format: 422910619
Labeler code: 42291
Product ID: 42291-619_d57e53ae-531e-964e-e053-2a95a90a2e0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: minoxidil
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA072709
Marketing category: ANDA
Marketing start: 2013-08-01
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 10 mg/1
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

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	Source date
excluded product	product	42291-619		D	Discontinued by firm	2026-08-03
excluded package	package	42291-619	42291-619-01	D	Discontinued by firm	2026-08-03
excluded package	package	42291-619	42291-619-90	D	Discontinued by firm	2026-08-03

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 · 12 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…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Application-product, TE code table
Application-product	TE code
A072709-001	AB
A072709-002	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 3 · 82 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
2026-02-19 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072709-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072709-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072709-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072709-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072709-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072709-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072709-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072709-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072709-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072709-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072709-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072709-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072709-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072709-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072709-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072709-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072709-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072709-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072709-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072709-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072709-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072709-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072709-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072709-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072709-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072709-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072709-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072709-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072709-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072709-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072709-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072709-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072709-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072709-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072709-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072709-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072709-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072709-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072709-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072709-002	AB	1	`782e0a99824c…`

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-619-01	MINOXIDIL	100 in 1 BOTTLE	TABLET	100		13
42291-619-90	MINOXIDIL	90 in 1 BOTTLE	TABLET	90		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-619-01	EA - Each	42291-619	aa0a976a-a209-4adc-b724-2162ba27f3ca	1	2014-09-03
42291-619-10	EA - Each	42291-619	8d4f171b-a7a5-44b5-aec8-57483c43547e	1	2013-10-17
42291-619-90	EA - Each	42291-619	3f487993-d01d-439a-a08c-6317270b2277	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
minoxidil	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2
minoxidil	ACTIVE MOIETY	5965120SH1	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-619	MINOXIDIL TABLET [AVKARE]	12	Legacy NDC, 2 package rows	20250112_02d7399f-94cc-f718-f214-587301edd138.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 · 5 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
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	AvKARE	02d7399f-94cc-f718-f214-587301edd138	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 42291-619
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

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
197986	minoxidil 10 MG Oral Tablet	PSN	02d7399f-94cc-f718-f214-587301edd138	13
197987	minoxidil 2.5 MG Oral Tablet	PSN	02d7399f-94cc-f718-f214-587301edd138	13
197986	minoxidil 10 MG Oral Tablet	SCD	02d7399f-94cc-f718-f214-587301edd138	13
197987	minoxidil 2.5 MG Oral Tablet	SCD	02d7399f-94cc-f718-f214-587301edd138	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-619-01	42291061901	100 TABLET in 1 BOTTLE (42291-619-01)	100 tablet	2013-08-01	0000-00-00	No	No	Current
42291-619-90	42291061990	90 in 1 BOTTLE						Historical