Midodrine Hydrochloride

Product NDC: 42291-562
11-digit product format: 422910562
Labeler code: 42291
Product ID: 42291-562_485ffcea-c65d-bf10-e063-6294a90a4ee1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA077746
Marketing category: ANDA
Marketing start: 2017-05-05
Substance: MIDODRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A077746-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12
A077746-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12
A077746-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077746-001	AB
A077746-002	AB
A077746-003	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 · 126 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	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077746-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077746-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077746-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2006-09-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077746-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077746-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077746-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077746-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077746-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077746-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077746-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077746-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077746-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077746-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077746-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077746-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077746-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077746-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077746-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077746-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077746-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077746-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077746-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077746-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077746-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077746-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077746-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077746-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077746-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077746-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077746-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077746-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077746-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077746-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077746-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077746-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077746-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077746-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077746-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077746-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077746-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077746-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077746-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077746-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Midodrine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDODRINE HYDROCHLORIDE	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993462	Internal RxNorm lookup
993466	Internal RxNorm lookup
993470	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
1c2e8707-550f-430f-87f3-4bb3d55f4aba	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
42291-562-90	Midodrine Hydrochloride	90 in 1 BOTTLE	TABLET	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-562-90	EA - Each	42291-562	3760d667-4604-4fcc-bc60-1b542ed6a703	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-562	MIDODRINE HYDROCHLORIDE TABLET [AVKARE]	4	Current NDC, Legacy NDC, 1 package rows	20231027_1c2e8707-550f-430f-87f3-4bb3d55f4aba.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	American Health Packaging	159cb0cb-4b27-4a1c-8ad4-dc93604c79c7	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	AvKARE	1c2e8707-550f-430f-87f3-4bb3d55f4aba	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746 ndc (product): 42291-562
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Cardinal Health 107, LLC	5e2443c2-f714-4b1d-bf2d-22742f411961	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Major Pharmaceuticals	164dce3b-1927-497e-884a-a2c72958beb9	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Apotex Corp	aec0d2de-ce83-b7c2-5d10-740607d50521	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	AvPAK	9106776e-601a-4e3c-e053-2995a90a5435	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	c41f7ec2-a3d7-4ff0-b51d-feda49717e7b	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077746 application number: ANDA077746

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
993462	midodrine HCl 10 MG Oral Tablet	PSN	1c2e8707-550f-430f-87f3-4bb3d55f4aba	5
993466	midodrine HCl 2.5 MG Oral Tablet	PSN	1c2e8707-550f-430f-87f3-4bb3d55f4aba	5
993470	midodrine HCl 5 MG Oral Tablet	PSN	1c2e8707-550f-430f-87f3-4bb3d55f4aba	5
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	1c2e8707-550f-430f-87f3-4bb3d55f4aba	5
993466	midodrine hydrochloride 2.5 MG Oral Tablet	SCD	1c2e8707-550f-430f-87f3-4bb3d55f4aba	5
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	1c2e8707-550f-430f-87f3-4bb3d55f4aba	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-562-90	42291056290	90 TABLET in 1 BOTTLE (42291-562-90)	90 tablet	2017-05-05	0000-00-00	No	No	Current