Midodrine Hydrochloride

Product NDC
85293-006
11-digit product format
852930006
Labeler code
85293
Product ID
85293-006_2fb355a4-09cf-880d-e063-6394a90a8178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Umasuto, LLC
Application
ANDA207613
Marketing category
ANDA
Marketing start
2025-03-05
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
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 HYDROCHLORIDE5 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
85293-006-01Midodrine Hydrochloride100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85293-006MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE) TABLET [UMASUTO, LLC]1Current NDC, 1 package rows20250313_4f5e1689-9691-471b-a39c-26120d6ce073.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN4f5e1689-9691-471b-a39c-26120d6ce0731
993466midodrine HCl 2.5 MG Oral TabletPSN4f5e1689-9691-471b-a39c-26120d6ce0731
993470midodrine HCl 5 MG Oral TabletPSN4f5e1689-9691-471b-a39c-26120d6ce0731
993462midodrine hydrochloride 10 MG Oral TabletSCD4f5e1689-9691-471b-a39c-26120d6ce0731
993466midodrine hydrochloride 2.5 MG Oral TabletSCD4f5e1689-9691-471b-a39c-26120d6ce0731
993470midodrine hydrochloride 5 MG Oral TabletSCD4f5e1689-9691-471b-a39c-26120d6ce0731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85293-006-0185293000601100 TABLET in 1 BOTTLE (85293-006-01) 100 tablet2025-03-05NoNoHistorical