Midodrine Hydrochloride

Product NDC: 71335-3037
11-digit product format: 713353037
Labeler code: 71335
Product ID: 71335-3037_aaaed4a4-358b-4f58-82ce-1ea0213f9fad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212774
Marketing category: ANDA
Marketing start: 2020-08-10
Substance: MIDODRINE HYDROCHLORIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDODRINE HYDROCHLORIDE	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
59JV96YTXV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993466	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
78d447cb-e3ff-433b-9758-b907a75b0666	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee08dc62-0af6-bb42-639c-6cdc4aad4b08	Product name	6	20250801

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-3037-1	Midodrine Hydrochloride	100 in 1 BOTTLE	TABLET	100		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-3037-1	EA - Each	71335-3037	8dcf7b3d-4a36-47f3-8204-e04120bdc228	1	2026-01-08

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 ndc (product): 71335-3037
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
59JV96YTXV	MIDODRINE HYDROCHLORIDE	43218-56-0	MIDODRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993466	midodrine HCl 2.5 MG Oral Tablet	PSN	78d447cb-e3ff-433b-9758-b907a75b0666	100
993466	midodrine hydrochloride 2.5 MG Oral Tablet	SCD	78d447cb-e3ff-433b-9758-b907a75b0666	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3037-1	71335303701	100 TABLET in 1 BOTTLE (71335-3037-1)	100 tablet	2025-12-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	100