MINOXIDIL

Product NDC: 53489-387
11-digit product format: 534890387
Labeler code: 53489
Product ID: 53489-387_4a668fcd-612e-6944-e063-6394a90a9e2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: minoxidil
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, 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: 2027-12-31
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.

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…`

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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0354a7f5-5917-44dc-9963-411104008cb5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53489-387-01	MINOXIDIL	100 in 1 BOTTLE	TABLET	100	5
53489-387-03	MINOXIDIL	250 in 1 BOTTLE	TABLET	250	5
53489-387-05	MINOXIDIL	500 in 1 BOTTLE	TABLET	500	5
53489-387-10	MINOXIDIL	1000 in 1 BOTTLE	TABLET	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-387-01	EA - Each	53489-387	7736437b-7e3a-4763-b744-f14192a6d690	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
minoxidil	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	3
minoxidil	ACTIVE MOIETY	5965120SH1	MINOXIDIL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	3
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
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
minoxidil	ACTIVE MOIETY	5965120SH1	MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-387	MINOXIDIL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 4 package rows	20171019_0354a7f5-5917-44dc-9963-411104008cb5.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
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 ndc (product): 53489-387
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
197986	minoxidil 10 MG Oral Tablet	PSN	f0dae476-8d0b-4d0c-a505-ad51bf27a1c8	10
197986	minoxidil 10 MG Oral Tablet	SCD	f0dae476-8d0b-4d0c-a505-ad51bf27a1c8	10
197986	minoxidil 10 MG Oral Tablet	PSN	0354a7f5-5917-44dc-9963-411104008cb5	5
197986	minoxidil 10 MG Oral Tablet	PSN	40da3ec5-39db-42f1-b0d6-39d852130307	5
197987	minoxidil 2.5 MG Oral Tablet	PSN	0354a7f5-5917-44dc-9963-411104008cb5	5
197986	minoxidil 10 MG Oral Tablet	SCD	0354a7f5-5917-44dc-9963-411104008cb5	5
197986	minoxidil 10 MG Oral Tablet	SCD	40da3ec5-39db-42f1-b0d6-39d852130307	5
197987	minoxidil 2.5 MG Oral Tablet	SCD	0354a7f5-5917-44dc-9963-411104008cb5	5
197986	minoxidil 10 MG Oral Tablet	PSN	abeeb857-8303-487a-83fc-de7396c6ea8b	2
197987	minoxidil 2.5 MG Oral Tablet	PSN	abeeb857-8303-487a-83fc-de7396c6ea8b	2
197986	minoxidil 10 MG Oral Tablet	SCD	abeeb857-8303-487a-83fc-de7396c6ea8b	2
197987	minoxidil 2.5 MG Oral Tablet	SCD	abeeb857-8303-487a-83fc-de7396c6ea8b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-387-01	53489038701	100 TABLET in 1 BOTTLE (53489-387-01)	100 tablet	1995-12-14	0000-00-00	No	No	Current
53489-387-03	53489038703	250 TABLET in 1 BOTTLE (53489-387-03)	250 tablet	1995-12-14	0000-00-00	No	No	Current
53489-387-05	53489038705	500 TABLET in 1 BOTTLE (53489-387-05)	500 tablet	1995-12-14	0000-00-00	No	No	Current
53489-387-10	53489038710	1000 TABLET in 1 BOTTLE (53489-387-10)	1000 tablet	1995-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MINOXIDIL TABLETS USP	PD-Rx Pharmaceuticals, Inc.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	11
MINOXIDIL TABLETS USP	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm, Inc.	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	5
Minoxidil Tablets USP	AvKARE	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	13
MINOXIDIL TABLETS USP	Bryant Ranch Prepack	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	5
MINOXIDIL TABLETS USP	DOH CENTRAL PHARMACY	2017-04-28	HUMAN PRESCRIPTION DRUG LABEL	2