Application 212774

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A212774-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10
A212774-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10
A212774-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212774-001	AB
A212774-002	AB
A212774-003	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 3 · 114 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	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212774-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212774-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212774-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-08-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A212774-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212774-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212774-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212774-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212774-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212774-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212774-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212774-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212774-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212774-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212774-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212774-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212774-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212774-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212774-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212774-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212774-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212774-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212774-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212774-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212774-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212774-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212774-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212774-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212774-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212774-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212774-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212774-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212774-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212774-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212774-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212774-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212774-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212774-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212774-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212774-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212774-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212774-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212774-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212774-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	78d447cb-e3ff-433b-9758-b907a75b0666	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212774 application number: ANDA212774
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	679b72bd-f50e-4075-a531-99372b5a4fac	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212774 application number: ANDA212774
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	dc03ebb7-f4cc-451a-927d-f8bfb6a3c805	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212774 application number: ANDA212774
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	db4b18d6-68f9-4d7c-9230-40b928cf859c	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212774 application number: ANDA212774
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212774 application number: ANDA212774 ndc (product): 0615-8384 ndc (product): 0615-8382 ndc (product): 0615-8383
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Aurobindo Pharma Limited	771b3e81-f15b-4d32-a1d8-c43b104d1f7b	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212774 application number: ANDA212774 ndc (product): 59651-248 ndc (product): 59651-247 ndc (product): 59651-246

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8382	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8382	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8383	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8383	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8384	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8384	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
59651-246	Midodrine Hydrochloride	Midodrine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-246	Midodrine Hydrochloride	Midodrine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-247	Midodrine Hydrochloride	Midodrine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-247	Midodrine Hydrochloride	Midodrine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-248	Midodrine Hydrochloride	Midodrine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-248	Midodrine Hydrochloride	Midodrine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current