Home NDC 55154-5623 Midodrine Hydrochloride
Product NDC 55154-5623
11-digit product format 551545623
Labeler code 55154
Product ID 55154-5623_757c92e0-bed9-4e57-93ff-afe8cc15d18b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midodrine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA076725
Marketing category ANDA
Marketing start 2004-11-03
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076725-001 ORVATEN MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2004-11-03 A076725-002 ORVATEN MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 2004-11-03 A076725-003 ORVATEN MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-11-03
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 · 129 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 2026-09-14 22:38:34 2026-08 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Midodrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDODRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-5623-0 Midodrine Hydrochloride 1 in 1 BLISTER PACK TABLET 1 10 55154-5623-0 Midodrine Hydrochloride 10 in 1 BAG TABLET 10 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5623 MIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250104_24847065-0be0-46eb-a084-7e5425a8be73.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 · 2 matching rows.
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 55154-5623-0 55154562300 10 BLISTER PACK in 1 BAG (55154-5623-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2004-11-03 0000-00-00 No No Current