Home NDC 0378-1902 Midodrine Hydrochloride
Product NDC 0378-1902
11-digit product format 003781902
Labeler code 0378
Product ID 0378-1902_e92f278e-0a58-49e3-8fc0-3a16b8474d3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midodrine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA076577
Marketing category ANDA
Marketing start 2003-09-11
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993462 Internal RxNorm lookup 993466 Internal RxNorm lookup 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 0378-1902-01 Midodrine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIDODRINE HYDROCHLORIDE ACTIVE INGREDIENT 59JV96YTXV MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MIDODRINE ACTIVE MOIETY 6YE7PBM15H MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MIDODRINE HYDROCHLORIDE ACTIVE INGREDIENT 59JV96YTXV MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 MIDODRINE ACTIVE MOIETY 6YE7PBM15H MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 MIDODRINE HYDROCHLORIDE ACTIVE INGREDIENT 59JV96YTXV MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 MIDODRINE HYDROCHLORIDE ACTIVE INGREDIENT 59JV96YTXV MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MIDODRINE ACTIVE MOIETY 6YE7PBM15H MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 MIDODRINE ACTIVE MOIETY 6YE7PBM15H MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1902 MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 1 package rows 20220930_32fad00b-7e7b-4d35-9e8b-fdc979fdb88e.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 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 ndc (product): 0378-1902
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 0378-1902-01 00378190201 100 TABLET in 1 BOTTLE, PLASTIC (0378-1902-01) 100 tablet 2003-09-11 0000-00-00 No No Current