Midodrine HCl

Product NDC: 0185-0149
11-digit product format: 001850149
Labeler code: 0185
Product ID: 0185-0149_b82311c6-0dfa-4d39-9db1-33e03163a2b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Eon Labs, Inc.
Application: ANDA076514
Marketing category: ANDA
Marketing start: 2002-07-02
Marketing end: 2021-10-31
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0185-0149		D	Discontinued by firm	2026-08-17
excluded package	package	0185-0149	0185-0149-01	D	Discontinued by firm	2026-08-17
excluded package	package	0185-0149	0185-0149-05	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0149-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0149-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0149-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0149-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0149-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0149-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0149-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0149-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0149-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0149-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0149-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0149-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0149-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0149-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0149-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0149-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0149-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0149-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0149-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0149-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0149-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0149-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0149-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0149-01	`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	Approval date
A076514-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11
A076514-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11
A076514-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076514-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2003-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076514-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2004-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076514-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2003-09-11	`1e350fbaab3a…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0149-01	EA - Each	0185-0149	4adbd845-7e2d-4071-948e-9150cd0cccc5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIDODRINE HYDROCHLORIDE	ACTIVE INGREDIENT	59JV96YTXV	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
MIDODRINE	ACTIVE MOIETY	6YE7PBM15H	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [EON LABS, INC.]	18
MIDODRINE HYDROCHLORIDE	ACTIVE INGREDIENT	59JV96YTXV	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MIDODRINE	ACTIVE MOIETY	6YE7PBM15H	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1

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	4a81751e-1c63-4b0d-8f63-bf7c4d155f22	1
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	4a81751e-1c63-4b0d-8f63-bf7c4d155f22	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0149-01	00185014901	100 TABLET in 1 BOTTLE (0185-0149-01)	100 tablet	2002-07-02	2021-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride Tablets, USP	Eon Labs, Inc.	2019-02-27	HUMAN PRESCRIPTION DRUG LABEL	21
Midodrine Hydrochloride Tablets 2.5 mg, 5 mg and 10 mg	Rebel Distributors Corp	2010-12-29	HUMAN PRESCRIPTION DRUG LABEL	1