Minoxidil

Product NDC: 68084-205
11-digit product format: 680840205
Labeler code: 68084
Product ID: 68084-205_43e0ff0a-c0e4-97fc-e063-6294a90ae3dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minoxidil
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA071839
Marketing category: ANDA
Marketing start: 2007-09-05
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 42.

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
A071839-001	MINOXIDIL	MINOXIDIL	10MG	TABLET / ORAL	AB		1988-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A071839-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071839-001	MINOXIDIL	10MG	TABLET / ORAL	AB	1988-11-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A071839-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071839-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071839-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071839-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071839-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071839-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071839-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071839-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071839-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071839-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071839-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071839-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071839-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071839-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071839-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071839-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071839-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071839-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071839-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071839-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071839-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071839-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071839-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071839-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071839-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071839-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071839-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071839-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071839-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071839-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071839-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071839-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071839-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071839-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071839-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071839-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071839-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071839-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071839-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071839-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Minoxidil
Listing expiration: 2026-12-31

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
0b4fc036-9497-442b-b629-c4b386932789	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-205-01	Minoxidil	100 in 1 BOX, UNIT-DOSE	TABLET	100		11
68084-205-11	Minoxidil	1 in 1 BLISTER PACK	TABLET	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-205-01	EA - Each	68084-205	1f03de78-8953-430f-a273-b187ea1ef0a4	1	2012-07-24
68084-205-11	EA - Each	68084-205	901540f3-1c87-476c-b4ee-ee55131424b6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3
MINOXIDIL	ACTIVE MOIETY	5965120SH1	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-205	MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]	10	Current NDC, Legacy NDC, 2 package rows	20241024_0b4fc036-9497-442b-b629-c4b386932789.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	665cba3d-5f26-468a-a047-188a413fbede	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	b138c404-028c-4a73-a127-c96f2072e1f8	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	e39469e6-d4f6-450f-872c-6f538e67c71a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	934508f8-9252-4d48-ae91-0ce96454dc7b	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Golden State Medical Supply, Inc.	1d134237-3e94-258e-e063-6294a90af556	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Par Health USA, LLC	8f3800f0-b6da-4dfe-8c32-39bb5eb0262a	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	American Health Packaging	0b4fc036-9497-442b-b629-c4b386932789	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839 ndc (product): 68084-205
Minoxidil	MINOXIDIL	A-S Medication Solutions	f00f3370-0313-4ce0-be7d-80db4477d9ae	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	6277d0dc-ac63-4393-a8ef-5350d9808876	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071839 application number: ANDA071839

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	0b4fc036-9497-442b-b629-c4b386932789	11
197987	minoxidil 2.5 MG Oral Tablet	PSN	0b4fc036-9497-442b-b629-c4b386932789	11
197986	minoxidil 10 MG Oral Tablet	SCD	0b4fc036-9497-442b-b629-c4b386932789	11
197987	minoxidil 2.5 MG Oral Tablet	SCD	0b4fc036-9497-442b-b629-c4b386932789	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-205-01	68084020501	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-205-01) / 1 TABLET in 1 BLISTER PACK (68084-205-11)	100 blister pack	2007-09-05	0000-00-00	No	No	Current
68084-205-11	68084020511	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Tablets, USP Rx Only 8020401/1025F	American Health Packaging	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	11