Midodrine Hydrochloride

Product NDC: 63739-145
Requested package NDC: 63739-145-10
11-digit product format: 637390145
Labeler code: 63739
Product ID: 63739-145_e82fa2f0-d741-1fa8-e053-2995a90a2ec3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: midodrine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation DBA SKY Packaging
Application: ANDA207849
Marketing category: ANDA
Marketing start: 2020-10-15
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: 2023-12-31
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	63739-145	63739-145-10	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
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-145-10	EA - Each	63739-145	3f2526fc-3e4e-4b52-a85b-62dd4aec396a	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-145	MIDODRINE HYDROCHLORIDE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]	10	Legacy NDC	20250112_e81e4324-8264-9ee6-e053-2995a90a8673.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-145-10	63739014510	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-145-10) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2022-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride - McKesson Corporation DBA SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	McKesson Corporation DBA SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	10