MIDODRINE HYDROCHLORIDE

Product NDC: 0115-4222
11-digit product format: 001154222
Labeler code: 0115
Product ID: 0115-4222_6adc2229-0675-45c0-b10d-10565489b80e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MIDODRINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Impax Generics
Application: ANDA076449
Marketing category: ANDA
Marketing start: 2004-05-27
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0115-4222		I	Inactivated by FDA	2026-08-17
excluded package	package	0115-4222	0115-4222-01	I	Inactivated by FDA	2026-08-17
excluded package	package	0115-4222	0115-4222-02	I	Inactivated by FDA	2026-08-17
excluded package	package	0115-4222	0115-4222-03	I	Inactivated by FDA	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 2 · 84 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	0115-4222-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-4222-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-4222-03	`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	0115-4222-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-4222-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-4222-03	`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	0115-4222-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-4222-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-4222-03	`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	0115-4222-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-4222-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-4222-03	`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	0115-4222-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-4222-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-4222-03	`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	0115-4222-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-4222-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-4222-03	`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	0115-4222-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-4222-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-4222-03	`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	0115-4222-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-4222-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-4222-03	`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	0115-4222-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-4222-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-4222-03	`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	0115-4222-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-4222-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-4222-03	`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	0115-4222-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-4222-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-4222-03	`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	0115-4222-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-4222-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-4222-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-4222-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-4222-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-4222-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-4222-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-4222-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-4222-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-4222-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-4222-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-4222-03	`1332a3947898…`	`d4bfe170f9cd…`

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
A076449-001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2004-05-27
A076449-002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2004-05-27
A076449-003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-16

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	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2004-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2004-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2005-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076449-002	MIDODRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076449-003	MIDODRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076449-001	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2004-05-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076449-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076449-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076449-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076449-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076449-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076449-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076449-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076449-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076449-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076449-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076449-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076449-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076449-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076449-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076449-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076449-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076449-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076449-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076449-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076449-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076449-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076449-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076449-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076449-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076449-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076449-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076449-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076449-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076449-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076449-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076449-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076449-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076449-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076449-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076449-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076449-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076449-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076449-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076449-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076449-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-4222-01	2020-01-31	C162847	48780-1	9d75b9d0-294d-f424-e053-dadaa90a57ce	MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg
0115-4222-02	2020-01-31	C162847	48780-1	9d75b9d0-294d-f424-e053-dadaa90a57ce	MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg
0115-4222-03	2020-01-31	C162847	48780-1	9d75b9d0-294d-f424-e053-dadaa90a57ce	MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0115-4222-01	MIDODRINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	7
0115-4222-02	MIDODRINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	7
0115-4222-03	MIDODRINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-4222-01	EA - Each	0115-4222	d8787424-7a74-4250-ae06-2afd517ae7bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIDODRINE HYDROCHLORIDE	ACTIVE INGREDIENT	59JV96YTXV	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
MIDODRINE	ACTIVE MOIETY	6YE7PBM15H	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [AVKARE, INC.]	6
MIDODRINE HYDROCHLORIDE	ACTIVE INGREDIENT	59JV96YTXV	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
MIDODRINE	ACTIVE MOIETY	6YE7PBM15H	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
MIDODRINE HYDROCHLORIDE	ACTIVE INGREDIENT	59JV96YTXV	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
MIDODRINE	ACTIVE MOIETY	6YE7PBM15H	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MIDODRINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-4222	MIDODRINE HYDROCHLORIDE TABLET [IMPAX GENERICS]	7	Legacy NDC, 3 package rows	20170605_e2e3db6b-054a-4f63-9936-482663c6395a.zip

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	e2e3db6b-054a-4f63-9936-482663c6395a	7
993466	midodrine HCl 2.5 MG Oral Tablet	PSN	e2e3db6b-054a-4f63-9936-482663c6395a	7
993470	midodrine HCl 5 MG Oral Tablet	PSN	e2e3db6b-054a-4f63-9936-482663c6395a	7
993462	midodrine hydrochloride 10 MG Oral Tablet	SCD	e2e3db6b-054a-4f63-9936-482663c6395a	7
993466	midodrine hydrochloride 2.5 MG Oral Tablet	SCD	e2e3db6b-054a-4f63-9936-482663c6395a	7
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	e2e3db6b-054a-4f63-9936-482663c6395a	7
993470	midodrine HCl 5 MG Oral Tablet	PSN	9d5c58cc-1713-47ff-acbd-5b1fc79f9944	3
993470	midodrine hydrochloride 5 MG Oral Tablet	SCD	9d5c58cc-1713-47ff-acbd-5b1fc79f9944	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0115-4222-01	00115422201	100 in 1 BOTTLE	Historical
0115-4222-02	00115422202	500 in 1 BOTTLE	Historical
0115-4222-03	00115422203	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midodrine HCl Tablets Rx Only	AvKARE, Inc.	2018-06-22	HUMAN PRESCRIPTION DRUG LABEL	8
MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg	Impax Generics	2017-02-27	HUMAN PRESCRIPTION DRUG LABEL	7
MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg	Carilion Materials Management	2016-08-04	HUMAN PRESCRIPTION DRUG LABEL	3