Midodrine Hydrochloride

Product NDC: 72789-468
11-digit product format: 727890468
Labeler code: 72789
Product ID: 72789-468_4db33e16-7f11-dc26-e063-6294a90a35df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA212543
Marketing category: ANDA
Marketing start: 2019-08-19
Substance: MIDODRINE HYDROCHLORIDE
Active strength: 5 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 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
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 · 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
2026-09-14 22:38:34	2026-08	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`84e616aacf4f…`
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…`

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
2026-09-14 22:38:34	2026-08	A212543-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212543-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212543-003	AB	1	`84e616aacf4f…`
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…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDODRINE HYDROCHLORIDE	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
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
52952ca6-bbce-4755-b73e-76a65f00a6bc	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
72789-468-01	Midodrine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		5
72789-468-90	Midodrine Hydrochloride	90 in 1 BOTTLE, PLASTIC	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
72789-468-01	EA - Each	72789-468	167f17f8-9485-4c52-af54-b8c816e39014	1	2025-02-10
72789-468-90	EA - Each	72789-468	d46da314-1016-4239-856d-18c8b98f6d5a	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-468	MIDODRINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20241228_52952ca6-bbce-4755-b73e-76a65f00a6bc.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	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 ndc (product): 72789-468
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
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

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
993470	midodrine HCl 5 MG Oral Tablet	PSN	52952ca6-bbce-4755-b73e-76a65f00a6bc	5
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	52952ca6-bbce-4755-b73e-76a65f00a6bc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-468-01	72789046801	100 TABLET in 1 BOTTLE, PLASTIC (72789-468-01)	100 tablet	2024-12-26	No	No	Current
72789-468-90	72789046890	90 TABLET in 1 BOTTLE, PLASTIC (72789-468-90)	90 tablet	2025-09-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	5