Midodrine Hydrochloride

Product NDC: 81469-139
11-digit product format: 814690139
Labeler code: 81469
Product ID: 81469-139_6e30fa38-fd26-4d37-a5f4-9e044c383362
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: First Nation Group, LLC
Application: ANDA217271
Marketing category: ANDA
Marketing start: 2025-08-13
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 43.

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
A217271-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01
A217271-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01
A217271-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217271-001	AB
A217271-002	AB
A217271-003	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 2 · 63 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
2026-09-14 22:38:34	2026-08	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217271-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217271-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217271-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-01	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217271-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217271-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217271-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217271-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217271-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217271-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217271-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217271-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217271-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217271-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217271-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217271-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217271-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217271-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217271-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217271-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217271-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217271-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217271-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217271-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217271-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217271-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217271-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217271-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217271-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217271-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217271-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217271-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217271-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217271-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
414cebaa-b87f-4d41-bc41-a77dcd3ea434	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
81469-139-90	Midodrine Hydrochloride	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81469-139-90	EA - Each	81469-139	3f289219-bed2-4410-9e03-4b6c4051e526	1	2025-09-12

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	NorthStar RxLLC	79b712a3-be12-4ea6-ac42-742826685ae5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217271 application number: ANDA217271
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Major Pharmaceuticals	dccf040b-e8de-40b5-9977-8b3e56830157	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217271 application number: ANDA217271
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	First Nation Group, LLC	414cebaa-b87f-4d41-bc41-a77dcd3ea434	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217271 application number: ANDA217271 ndc (product): 81469-139
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Coupler LLC	2d1b58a7-ec7f-f3ea-e063-6294a90a27fb	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217271 application number: ANDA217271
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Lifestar Pharma LLC	99d4aa03-81f7-4b43-a7b4-4ecc5ad13304	2023-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217271 application number: ANDA217271

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	414cebaa-b87f-4d41-bc41-a77dcd3ea434	1
993466	midodrine HCl 2.5 MG Oral Tablet	PSN	414cebaa-b87f-4d41-bc41-a77dcd3ea434	1
993470	midodrine HCl 5 MG Oral Tablet	PSN	414cebaa-b87f-4d41-bc41-a77dcd3ea434	1
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	414cebaa-b87f-4d41-bc41-a77dcd3ea434	1
993466	midodrine hydrochloride 2.5 MG Oral Tablet	SCD	414cebaa-b87f-4d41-bc41-a77dcd3ea434	1
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	414cebaa-b87f-4d41-bc41-a77dcd3ea434	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81469-139-90	81469013990	90 TABLET in 1 BOTTLE (81469-139-90)	90 tablet	2025-08-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride Tablets, USP Rx only	First Nation Group, LLC \| Mankind Pharma Limited	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL	1