Home NDC 64980-434 Midodrine Hydrochloride
Product NDC 64980-434
11-digit product format 649800434
Labeler code 64980
Product ID 64980-434_311a8e3c-0112-4c91-a7cc-92709b41f170
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midodrine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207613
Marketing category ANDA
Marketing start 2019-04-01
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 A207613-001 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 A207613-002 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 A207613-003 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02
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 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207613-002 MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207613-003 MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207613-001 MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2018-11-02 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 64980-434-01 Midodrine Hydrochloride 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-434 MIDODRINE HYDROCHLORIDE TABLET [RISING PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20190401_ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Rising Pharma Holdings, Inc. ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e 2025-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207613 application number: ANDA207613 ndc (product): 64980-434 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Umasuto, LLC 4f5e1689-9691-471b-a39c-26120d6ce073 2025-03-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207613 application number: ANDA207613 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Bryant Ranch Prepack 2be17e48-8258-4f29-914b-7f0fe9ace7a1 2020-10-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207613 application number: ANDA207613
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 64980-434-01 64980043401 100 TABLET in 1 BOTTLE (64980-434-01) 100 tablet 2019-04-01 0000-00-00 No No Current