Midodrine Hydrochloride

Product NDC: 63629-2346
11-digit product format: 636292346
Labeler code: 63629
Product ID: 63629-2346_8bfa3b96-7a9d-411c-b193-be6de1269691
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: midodrine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207849
Marketing category: ANDA
Marketing start: 2020-10-15
Substance: MIDODRINE HYDROCHLORIDE
Active strength: 10 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

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
A207849-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01
A207849-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01
A207849-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207849-001	AB
A207849-002	AB
A207849-003	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	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207849-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-10-01	`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	A207849-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207849-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207849-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207849-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207849-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207849-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207849-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207849-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207849-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207849-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207849-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207849-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207849-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207849-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207849-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207849-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207849-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207849-001	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	10 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
993462	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
df43f108-c89c-49e7-9c1a-77a0ce9b03b5	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
63629-2346-1	Midodrine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2346-1	EA - Each	63629-2346	99031228-e605-47d8-ac59-e08c42135f5e	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2346	MIDODRINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20240112_df43f108-c89c-49e7-9c1a-77a0ce9b03b5.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 · 9 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	78446de1-81f6-4764-98f3-44b4057f2175	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	572edc14-3450-46db-bec6-9d63e620a364	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	9c1ccd24-3f9c-489c-9fd2-98e69531d5ab	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	6498f9ab-3345-4343-918e-9c5014d6dd80	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	df43f108-c89c-49e7-9c1a-77a0ce9b03b5	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849 ndc (product): 63629-2346
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Bryant Ranch Prepack	7ec8fb86-18c4-4751-87e4-ca1e9e885088	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c4d0b757-bb6e-4df4-e053-2995a90a3042	2023-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Proficient Rx LP	0aebf5f9-8cfa-4b77-ba40-821ce0a2b266	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849
Midodrine Hydrochloride	MIDODRINE HYDROCHLORIDE	Xiromed, LLC	a4332a41-2a0a-a14a-9ce5-1465f39ff725	2020-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207849 application number: ANDA207849

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	df43f108-c89c-49e7-9c1a-77a0ce9b03b5	103
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	df43f108-c89c-49e7-9c1a-77a0ce9b03b5	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2346-1	63629234601	100 TABLET in 1 BOTTLE, PLASTIC (63629-2346-1)	100 tablet	2021-04-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	103