MINOXIDIL

Product NDC: 63629-1085
11-digit product format: 636291085
Labeler code: 63629
Product ID: 63629-1085_5ac6139f-ac3b-47aa-bfd6-8b2dd39c8e72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: minoxidil
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA072709
Marketing category: ANDA
Marketing start: 2020-07-05
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 3 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-1085		D	Discontinued by firm		2026-08-03
excluded package	package	63629-1085	63629-1085-1	D	Discontinued by firm		2026-08-03

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1085-1	EA - Each	63629-1085	1f01dce6-314b-4ee6-ab1f-663b8041e7c1	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1085	MINOXIDIL TABLET [BRYANT RANCH PREPACK]	5	Legacy NDC	20240110_da351da6-1b0d-4dd8-a24b-8b219c07afbf.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1085-1	63629108501	500 TABLET in 1 BOTTLE (63629-1085-1)	500 tablet	2020-07-05	0000-00-00	No	No	Current