Midodrine hydrochloride

Product NDC
70771-1596
11-digit product format
707711596
Labeler code
70771
Product ID
70771-1596_027de750-bb64-4f6c-87ee-9c73862af579
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA213055
Marketing category
ANDA
Marketing start
2020-09-17
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
70771-1596-1Midodrine hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1596MIDODRINE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 1 package rows20231103_b4c4417e-d8fd-46c8-b82f-ffbc8f201752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNb4c4417e-d8fd-46c8-b82f-ffbc8f2017522
993466midodrine HCl 2.5 MG Oral TabletPSNb4c4417e-d8fd-46c8-b82f-ffbc8f2017522
993470midodrine HCl 5 MG Oral TabletPSNb4c4417e-d8fd-46c8-b82f-ffbc8f2017522
993462midodrine hydrochloride 10 MG Oral TabletSCDb4c4417e-d8fd-46c8-b82f-ffbc8f2017522
993466midodrine hydrochloride 2.5 MG Oral TabletSCDb4c4417e-d8fd-46c8-b82f-ffbc8f2017522
993470midodrine hydrochloride 5 MG Oral TabletSCDb4c4417e-d8fd-46c8-b82f-ffbc8f2017522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1596-170771159601100 TABLET in 1 BOTTLE (70771-1596-1) 100 tablet2020-09-170000-00-00NoNoCurrent