Midodrine Hydrochloride

Product NDC
52817-323
11-digit product format
528170323
Labeler code
52817
Product ID
52817-323_b8d7c553-3894-7d6d-e053-2a95a90ae868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midodrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59JV96YTXV
Rxcui993462, 993466, 993470

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
52817-323-10Midodrine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-323MIDODRINE HYDROCHLORIDE TABLET [TRUPHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20210114_a88cd5b5-bdcb-4ef7-8b04-ee4603bcd621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNa88cd5b5-bdcb-4ef7-8b04-ee4603bcd6212
993466midodrine HCl 2.5 MG Oral TabletPSNa88cd5b5-bdcb-4ef7-8b04-ee4603bcd6212
993470midodrine HCl 5 MG Oral TabletPSNa88cd5b5-bdcb-4ef7-8b04-ee4603bcd6212
993462midodrine hydrochloride 10 MG Oral TabletSCDa88cd5b5-bdcb-4ef7-8b04-ee4603bcd6212
993466midodrine hydrochloride 2.5 MG Oral TabletSCDa88cd5b5-bdcb-4ef7-8b04-ee4603bcd6212
993470midodrine hydrochloride 5 MG Oral TabletSCDa88cd5b5-bdcb-4ef7-8b04-ee4603bcd6212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-323-1052817032310100 TABLET in 1 BOTTLE (52817-323-10) 100 tablet2019-08-190000-00-00NoNoCurrent