Midodrine Hydrochloride

Product NDC: 70985-006
11-digit product format: 709850006
Labeler code: 70985
Product ID: 70985-006_cfd290fe-1a8c-c40c-e053-2995a90afb10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Drug Ocean LLC
Application: ANDA207613
Marketing category: ANDA
Marketing start: 2020-06-19
Marketing end: 0000-00-00
Substance: MIDODRINE HYDROCHLORIDE
Active strength: 3 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70985-006		D	Discontinued by firm		2026-08-17
excluded package	package	70985-006	70985-006-01	D	Discontinued by firm		2026-08-17

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
A207613-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02
A207613-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02
A207613-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207613-001	AB
A207613-002	AB
A207613-003	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	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207613-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207613-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207613-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-11-02	`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	A207613-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207613-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207613-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207613-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207613-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207613-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207613-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207613-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207613-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207613-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207613-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207613-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207613-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207613-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207613-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207613-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207613-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207613-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207613-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207613-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207613-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207613-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207613-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207613-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207613-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207613-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207613-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207613-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207613-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207613-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207613-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207613-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207613-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207613-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207613-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207613-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207613-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207613-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207613-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207613-001	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee08dc62-0af6-bb42-639c-6cdc4aad4b08	Product name	6	20250801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70985-006	MIDODRINE HYDROCHLORIDE TABLET [DRUG OCEAN LLC]	3	Legacy NDC	20231224_70f909b8-461c-4929-8a92-83c5bb5e6f6b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207613 application number: ANDA207613
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Umasuto, LLC	4f5e1689-9691-471b-a39c-26120d6ce073	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207613 application number: ANDA207613
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	2be17e48-8258-4f29-914b-7f0fe9ace7a1	2020-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207613 application number: ANDA207613

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
59JV96YTXV	MIDODRINE HYDROCHLORIDE	43218-56-0	MIDODRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70985-006-01	70985000601	100 TABLET in 1 BOTTLE (70985-006-01)	100 tablet	2020-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MIDODRINE HYDROCHLORIDE TABLETS, USP 2.5 mg, 5 mg and 10 mg	Drug Ocean LLC \| Unique Pharmaceutical Laboratories	2025-11-02	HUMAN PRESCRIPTION DRUG LABEL	4