Midodrine Hydrochloride

Product NDC
50268-563
11-digit product format
502680563
Labeler code
50268
Product ID
50268-563_32fa2977-8701-5efb-e063-6394a90a2dff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA077746
Marketing category
ANDA
Marketing start
2019-08-26
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
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 HYDROCHLORIDE10 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
50268-563-15Midodrine Hydrochloride50 in 1 BOXTABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-563-15EA - Each50268-56364ede4d3-80e8-472c-8156-74bd1b6ca23a12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-563MIDODRINE HYDROCHLORIDE TABLET [AVPAK]4Current NDC, Legacy NDC, 1 package rows20250418_9106776e-601a-4e3c-e053-2995a90a5435.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN9106776e-601a-4e3c-e053-2995a90a54354
993466midodrine HCl 2.5 MG Oral TabletPSN9106776e-601a-4e3c-e053-2995a90a54354
993470midodrine HCl 5 MG Oral TabletPSN9106776e-601a-4e3c-e053-2995a90a54354
993462midodrine hydrochloride 10 MG Oral TabletSCD9106776e-601a-4e3c-e053-2995a90a54354
993466midodrine hydrochloride 2.5 MG Oral TabletSCD9106776e-601a-4e3c-e053-2995a90a54354
993470midodrine hydrochloride 5 MG Oral TabletSCD9106776e-601a-4e3c-e053-2995a90a54354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-563-155026805631550 TABLET in 1 BOX (50268-563-15) 50 tablet2019-08-260000-00-00NoNoCurrent