Midodrine Hydrochloride

Product NDC: 63629-7983
Requested package NDC: 63629-7983-1
11-digit product format: 636297983
Labeler code: 63629
Product ID: 63629-7983_97f2cbac-4f72-4cee-8817-faa2e827f306
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207169
Marketing category: ANDA
Marketing start: 2018-10-29
Marketing end: 0000-00-00
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-7983	63629-7983-1	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A207169-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29
A207169-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29
A207169-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207169-001	AB
A207169-002	AB
A207169-003	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	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207169-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2018-10-29	`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	A207169-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207169-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207169-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207169-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207169-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207169-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207169-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207169-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207169-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207169-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207169-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207169-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207169-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207169-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207169-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207169-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207169-001	AB	1	`1e350fbaab3a…`

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	Endo USA, Inc.	863f12bd-d4a9-4547-8667-5dfa9e2ce6d1	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207169 application number: ANDA207169
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	17b24a0b-03e4-4b58-87ab-3d66fec30226	2023-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207169 application number: ANDA207169
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	5a6705af-bb72-4edb-863a-93a351bd6dba	2023-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207169 application number: ANDA207169

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
63629-7983-1	63629798301	30 TABLET in 1 BOTTLE (63629-7983-1)	30 tablet	2019-04-08	0000-00-00	No	No	Current