Midodrine Hydrochloride

Product NDC
63629-2348
11-digit product format
636292348
Labeler code
63629
Product ID
63629-2348_04857555-d592-4a19-b2a0-55ca6fa43cb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207849
Marketing category
ANDA
Marketing start
2020-10-15
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
Rxcui993466

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
63629-2348-1Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2348-1EA - Each63629-234888a1591b-cdc2-42eb-8526-5c032e8aed3b12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2348MIDODRINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240112_6498f9ab-3345-4343-918e-9c5014d6dd80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993466midodrine HCl 2.5 MG Oral TabletPSN6498f9ab-3345-4343-918e-9c5014d6dd80102
993466midodrine hydrochloride 2.5 MG Oral TabletSCD6498f9ab-3345-4343-918e-9c5014d6dd80102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2348-163629234801100 TABLET in 1 BOTTLE, PLASTIC (63629-2348-1) 100 tablet2021-04-190000-00-00NoNoCurrent