Minoxidil

Product NDC: 68788-8273
11-digit product format: 687888273
Labeler code: 68788
Product ID: 68788-8273_266f1046-bc25-4bcf-8002-cb11e37f20e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minoxidil
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA071826
Marketing category: ANDA
Marketing start: 2022-10-13
Substance: MINOXIDIL
Active strength: 2.5 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
A071826-001	MINOXIDIL	MINOXIDIL	2.5MG	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
A071826-001	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	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071826-001	MINOXIDIL	2.5MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071826-001	MINOXIDIL	2.5MG	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	A071826-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071826-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071826-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071826-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071826-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071826-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071826-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071826-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071826-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071826-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071826-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071826-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071826-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071826-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071826-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071826-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071826-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071826-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071826-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071826-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071826-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071826-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071826-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071826-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071826-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071826-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071826-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071826-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071826-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071826-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071826-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071826-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071826-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071826-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071826-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071826-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071826-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071826-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071826-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071826-001	AB	1	`e64feba35796…`

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
cdfd3330-4836-4655-80a2-441380529a67	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8273-3	Minoxidil	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8273-3	EA - Each	68788-8273	a710c333-347e-4aa7-a371-8d4d334e076b	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8273	MINOXIDIL TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240719_cdfd3330-4836-4655-80a2-441380529a67.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Preferred Pharmaceuticals Inc.	cdfd3330-4836-4655-80a2-441380529a67	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826 ndc (product): 68788-8273
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	75b2832c-0a6c-4125-9514-19a6d8dbf6cf	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
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): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Par Health USA, LLC	8f3800f0-b6da-4dfe-8c32-39bb5eb0262a	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	NuCare Pharmaceuticals, Inc.	2e5a2976-06fb-43f9-e063-6294a90a3bf5	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	American Health Packaging	0b4fc036-9497-442b-b629-c4b386932789	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	A-S Medication Solutions	6c85c69e-b5af-4e98-aacf-f65ad15d00d7	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Proficient Rx LP	a0066eac-cb58-49ef-a480-105cb1043c2b	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	b18e42ee-e5fa-441f-a6b6-1eb17836d668	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	7aa8d272-0e44-43df-9263-9d84b2aa8946	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071826 application number: ANDA071826

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	cdfd3330-4836-4655-80a2-441380529a67	4
197987	minoxidil 2.5 MG Oral Tablet	SCD	cdfd3330-4836-4655-80a2-441380529a67	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8273-3	68788827303	30 TABLET in 1 BOTTLE (68788-8273-3)	30 tablet	2022-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Tablets, USP Rx only	Preferred Pharmaceuticals Inc. \| Preferred Pharmaceuticals, Inc.	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	5