Midodrine Hydrochloride

Product NDC
72789-465
11-digit product format
727890465
Labeler code
72789
Product ID
72789-465_4db2c537-ceff-22f5-e063-6294a90a2a75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA212543
Marketing category
ANDA
Marketing start
2019-08-19
Substance
MIDODRINE HYDROCHLORIDE
Active strength
2.5 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

Additional Listing Data#

Finished product
Yes
Brand name base
Midodrine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDODRINE HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59JV96YTXV
Rxcui993466

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee08dc62-0af6-bb42-639c-6cdc4aad4b08Product name620250801

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-465-01Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1004
72789-465-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-465-01EA - Each72789-465d603ac56-6041-42af-a029-58560d54819512025-02-10
72789-465-90EA - Each72789-465cb821847-b828-470b-93c4-ab30c6ba3f4412025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-465MIDODRINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241228_54ded041-c78c-4646-a1cc-c94afcd62690.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993466midodrine HCl 2.5 MG Oral TabletPSN54ded041-c78c-4646-a1cc-c94afcd626904
993466midodrine hydrochloride 2.5 MG Oral TabletSCD54ded041-c78c-4646-a1cc-c94afcd626904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-465-0172789046501100 TABLET in 1 BOTTLE, PLASTIC (72789-465-01) 100 tablet2024-12-26NoNoCurrent
72789-465-907278904659090 TABLET in 1 BOTTLE, PLASTIC (72789-465-90) 90 tablet2025-09-05NoNoCurrent