Midodrine Hydrochloride

Product NDC
72789-468
11-digit product format
727890468
Labeler code
72789
Product ID
72789-468_4db33e16-7f11-dc26-e063-6294a90a35df
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
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59JV96YTXV
Rxcui993470

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
72789-468-01Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1005
72789-468-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-468-01EA - Each72789-468167f17f8-9485-4c52-af54-b8c816e3901412025-02-10
72789-468-90EA - Each72789-468d46da314-1016-4239-856d-18c8b98f6d5a12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-468MIDODRINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241228_52952ca6-bbce-4755-b73e-76a65f00a6bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993470midodrine HCl 5 MG Oral TabletPSN52952ca6-bbce-4755-b73e-76a65f00a6bc5
993470midodrine hydrochloride 5 MG Oral TabletSCD52952ca6-bbce-4755-b73e-76a65f00a6bc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-468-0172789046801100 TABLET in 1 BOTTLE, PLASTIC (72789-468-01) 100 tablet2024-12-26NoNoHistorical
72789-468-907278904689090 TABLET in 1 BOTTLE, PLASTIC (72789-468-90) 90 tablet2025-09-05NoNoHistorical