Midodrine Hydrochloride

Product NDC
51407-389
11-digit product format
514070389
Labeler code
51407
Product ID
51407-389_0712935b-edf7-9614-e063-6294a90a9906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA207849
Marketing category
ANDA
Marketing start
2020-10-01
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
51407-389-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-389-90EA - Each51407-38997d40357-6ad1-4b0a-aa4e-17b7c28c1d1712021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-389MIDODRINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, Legacy NDC, 1 package rows20231007_c4d0b757-bb6e-4df4-e053-2995a90a3042.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993466midodrine HCl 2.5 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993470midodrine HCl 5 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993462midodrine hydrochloride 10 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993466midodrine hydrochloride 2.5 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993470midodrine hydrochloride 5 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-389-905140703899090 TABLET in 1 BOTTLE, PLASTIC (51407-389-90) 90 tablet2021-04-090000-00-00NoNoCurrent