Midodrine Hydrochloride

Product NDC: 0615-8383
Requested package NDC: 0615-8383-39
11-digit product format: 006158383
Labeler code: 0615
Product ID: 0615-8383_8970ba1c-ea60-4d30-be3b-e53b1bdc7871
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA212774
Marketing category: ANDA
Marketing start: 2020-08-10
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-8383	0615-8383-39	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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
6c089bcf-c3ac-44c3-9336-8358c4d81bcd	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
0615-8383-05	Midodrine Hydrochloride	15 in 1 BLISTER PACK	TABLET	15		5
0615-8383-39	Midodrine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8383	MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	5	Current NDC, Legacy NDC, 2 package rows	20240918_6c089bcf-c3ac-44c3-9336-8358c4d81bcd.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 · 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
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 ndc (package): 0615-8383-39 ndc (product): 0615-8383 ndc11 (package): 00615838339
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
993462	midodrine HCl 10 MG Oral Tablet	PSN	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	5
993466	midodrine HCl 2.5 MG Oral Tablet	PSN	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	5
993470	midodrine HCl 5 MG Oral Tablet	PSN	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	5
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	5
993466	midodrine hydrochloride 2.5 MG Oral Tablet	SCD	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	5
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	6c089bcf-c3ac-44c3-9336-8358c4d81bcd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8383-39	00615838339	30 TABLET in 1 BLISTER PACK (0615-8383-39)	30 tablet	2021-02-09	2024-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-16	HUMAN PRESCRIPTION DRUG LABEL	5