Midodrine Hydrochloride

Product NDC
72789-467
11-digit product format
727890467
Labeler code
72789
Product ID
72789-467_4db33362-9044-f731-e063-6294a90a1809
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
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59JV96YTXV
Rxcui993462

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
72789-467-01Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1004
72789-467-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-467MIDODRINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241228_5c83cb11-0920-4049-bd6d-c9df0d8a5423.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN5c83cb11-0920-4049-bd6d-c9df0d8a54234
993462midodrine hydrochloride 10 MG Oral TabletSCD5c83cb11-0920-4049-bd6d-c9df0d8a54234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-467-0172789046701100 TABLET in 1 BOTTLE, PLASTIC (72789-467-01) 100 tablet2024-12-26NoNoCurrent
72789-467-907278904679090 TABLET in 1 BOTTLE, PLASTIC (72789-467-90) 90 tablet2024-09-05NoNoCurrent