Home NDC 70756-050 Midodrine Hydrochloride
Product NDC 70756-050
11-digit product format 707560050
Labeler code 70756
Product ID 70756-050_e8d87cc3-32ad-45ec-9e23-9e15d92e66b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midodrine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lifestar Pharma LLC
Application ANDA217271
Marketing category ANDA
Marketing start 2023-11-01
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 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 A217271-001 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 A217271-002 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 A217271-003 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01
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 2 · 60 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 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217271-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217271-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217271-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-01 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 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 10 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 70756-050-11 Midodrine Hydrochloride 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70756-050 MIDODRINE HYDROCHLORIDE TABLET [LIFESTAR PHARMA LLC] 4 Current NDC, 1 package rows 20231104_99d4aa03-81f7-4b43-a7b4-4ecc5ad13304.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 NorthStar RxLLC 79b712a3-be12-4ea6-ac42-742826685ae5 2026-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217271 application number: ANDA217271 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE First Nation Group, LLC 414cebaa-b87f-4d41-bc41-a77dcd3ea434 2025-08-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217271 application number: ANDA217271 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Coupler LLC 2d1b58a7-ec7f-f3ea-e063-6294a90a27fb 2025-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217271 application number: ANDA217271 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Lifestar Pharma LLC 99d4aa03-81f7-4b43-a7b4-4ecc5ad13304 2023-11-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217271 application number: ANDA217271 ndc (product): 70756-050
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70756-050-11 70756005011 100 TABLET in 1 BOTTLE (70756-050-11) 100 tablet 2023-11-01 No No Current