Application 212543

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212543-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19
A212543-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19
A212543-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212543-001	AB
A212543-002	AB
A212543-003	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 4 · 123 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	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A212543-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212543-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212543-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212543-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212543-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212543-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212543-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212543-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212543-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212543-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212543-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212543-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212543-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212543-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212543-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212543-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212543-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212543-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212543-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212543-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212543-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212543-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212543-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212543-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212543-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212543-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212543-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212543-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212543-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212543-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212543-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212543-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212543-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212543-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212543-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212543-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-001	AB	1	`1e350fbaab3a…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	54ded041-c78c-4646-a1cc-c94afcd62690	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5c83cb11-0920-4049-bd6d-c9df0d8a5423	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	52952ca6-bbce-4755-b73e-76a65f00a6bc	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Advagen Pharma Limited	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543 ndc (product): 72888-114 ndc (product): 72888-112 ndc (product): 72888-113
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	NorthStar Rx LLC	b015c98f-57e6-410b-9c9d-8898aa22082a	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	60d5a132-9cfc-48e2-aa71-1949aeb255c3	2023-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	TruPharma, LLC	a88cd5b5-bdcb-4ef7-8b04-ee4603bcd621	2021-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212543 application number: ANDA212543 ndc (product): 52817-325 ndc (product): 52817-323 ndc (product): 52817-324

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52817-323	Midodrine Hydrochloride	Midodrine Hydrochloride	TruPharma, LLC	ANDA	Current
52817-323	Midodrine Hydrochloride	Midodrine Hydrochloride	TruPharma, LLC	ANDA	Current
52817-324	Midodrine Hydrochloride	Midodrine Hydrochloride	TruPharma, LLC	ANDA	Current
52817-324	Midodrine Hydrochloride	Midodrine Hydrochloride	TruPharma, LLC	ANDA	Current
52817-325	Midodrine Hydrochloride	Midodrine Hydrochloride	TruPharma, LLC	ANDA	Current
52817-325	Midodrine Hydrochloride	Midodrine Hydrochloride	TruPharma, LLC	ANDA	Current
71335-2174	Midodrine Hydrochloride	Midodrine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72888-112	Midodrine Hydrochloride	Midodrine Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-113	Midodrine Hydrochloride	Midodrine Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-114	Midodrine Hydrochloride	Midodrine Hydrochloride	Advagen Pharma Limited	ANDA	Current