Midodrine Hydrochloride

Product NDC: 72888-113
Requested package NDC: 72888-113-01
11-digit product format: 728880113
Labeler code: 72888
Product ID: 72888-113_4844f53c-e67e-147e-e063-6394a90ae79b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Advagen Pharma Limited
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 1.

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 3 · 120 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212543-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-08-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212543-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212543-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212543-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (package): 72888-113-01 ndc (product): 72888-113 ndc11 (package): 72888011301
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

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 · 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
8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	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
72888-113-01	Midodrine Hydrochloride	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-113-01	EA - Each	72888-113	95b8e35a-dc57-4a05-bdec-5ab4406111df	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-113	MIDODRINE HYDROCHLORIDE TABLET [ADVAGEN PHARMA LIMITED]	1	Current NDC, Legacy NDC, 1 package rows	20210918_8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb.zip

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
993462	midodrine HCl 10 MG Oral Tablet	PSN	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2
993466	midodrine HCl 2.5 MG Oral Tablet	PSN	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2
993470	midodrine HCl 5 MG Oral Tablet	PSN	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2
993466	midodrine hydrochloride 2.5 MG Oral Tablet	SCD	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	8cf90a48-d4a1-4099-b6e1-52d2eaaad1bb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72888-113-01	72888011301	100 TABLET in 1 BOTTLE (72888-113-01)	100 tablet	2019-08-19	0000-00-00	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
Midodrine Hydrochloride Tablets, USP	Advagen Pharma Limited \| Rubicon Research Limited	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Midodrine Hydrochloride Tablets, USP	Bryant Ranch Prepack	2022-10-10	HUMAN PRESCRIPTION DRUG LABEL	100