FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
59651-247
11-digit product format
596510247
Labeler code
59651
Product ID
59651-247_fc0c51f9-da23-4083-ae88-c4bd5d8ad44b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA212774
Marketing category
ANDA
Marketing start
2020-08-10
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
59651-247-01Midodrine Hydrochloride100 in 1 BOTTLETABLET1003
59651-247-01Midodrine Hydrochloride1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-247MIDODRINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, Legacy NDC, 2 package rows20240207_771b3e81-f15b-4d32-a1d8-c43b104d1f7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993470midodrine HCl 5 MG Oral TabletPSN679b72bd-f50e-4075-a531-99372b5a4fac100
993470midodrine hydrochloride 5 MG Oral TabletSCD679b72bd-f50e-4075-a531-99372b5a4fac100
993462midodrine HCl 10 MG Oral TabletPSN6c089bcf-c3ac-44c3-9336-8358c4d81bcd5
993466midodrine HCl 2.5 MG Oral TabletPSN6c089bcf-c3ac-44c3-9336-8358c4d81bcd5
993470midodrine HCl 5 MG Oral TabletPSN6c089bcf-c3ac-44c3-9336-8358c4d81bcd5
993462midodrine hydrochloride 10 MG Oral TabletSCD6c089bcf-c3ac-44c3-9336-8358c4d81bcd5
993466midodrine hydrochloride 2.5 MG Oral TabletSCD6c089bcf-c3ac-44c3-9336-8358c4d81bcd5
993470midodrine hydrochloride 5 MG Oral TabletSCD6c089bcf-c3ac-44c3-9336-8358c4d81bcd5
993462midodrine HCl 10 MG Oral TabletPSN771b3e81-f15b-4d32-a1d8-c43b104d1f7b3
993466midodrine HCl 2.5 MG Oral TabletPSN771b3e81-f15b-4d32-a1d8-c43b104d1f7b3
993470midodrine HCl 5 MG Oral TabletPSN771b3e81-f15b-4d32-a1d8-c43b104d1f7b3
993462midodrine hydrochloride 10 MG Oral TabletSCD771b3e81-f15b-4d32-a1d8-c43b104d1f7b3
993466midodrine hydrochloride 2.5 MG Oral TabletSCD771b3e81-f15b-4d32-a1d8-c43b104d1f7b3
993470midodrine hydrochloride 5 MG Oral TabletSCD771b3e81-f15b-4d32-a1d8-c43b104d1f7b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-247-01596510247011 BOTTLE in 1 CARTON (59651-247-01) / 100 TABLET in 1 BOTTLE1 bottle2020-08-100000-00-00NoNoCurrent