Home NDC 51079-453 Midodrine Hydrochloride
Product NDC 51079-453
11-digit product format 510790453
Labeler code 51079
Product ID 51079-453_3a8743bb-679f-ae20-e063-6394a90a41c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midodrine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA076577
Marketing category ANDA
Marketing start 2006-09-11
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 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 RLD / RS Approval date A076577-001 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 A076577-002 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 A076577-003 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076577-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2003-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076577-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2003-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076577-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2003-09-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 5 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 993470 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51079-453-01 Midodrine Hydrochloride 1 in 1 BLISTER PACK TABLET 1 13 51079-453-20 Midodrine Hydrochloride 100 in 1 CARTON TABLET 100 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-453 MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 12 Current NDC, Legacy NDC, 2 package rows 20231228_fd28d383-add9-42a9-ad07-4d7e89f12460.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Safecor Health LLC 6ab70071-e733-44e2-bcc3-f08227901b29 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076577 application number: ANDA076577 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Cardinal Health 107, LLC 66bccee4-b466-4fe9-89d6-8c9eaaa92413 2025-10-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076577 application number: ANDA076577 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Mylan Institutional Inc. fd28d383-add9-42a9-ad07-4d7e89f12460 2025-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076577 application number: ANDA076577 ndc (product): 51079-453 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Mylan Pharmaceuticals Inc. 32fad00b-7e7b-4d35-9e8b-fdc979fdb88e 2022-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076577 application number: ANDA076577
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51079-453-01 51079045301 1 in 1 BLISTER PACK Historical 51079-453-20 51079045320 100 BLISTER PACK in 1 CARTON (51079-453-20) / 1 TABLET in 1 BLISTER PACK (51079-453-01) 100 blister pack 2006-09-11 0000-00-00 No No Current