Midodrine Hydrochloride

Product NDC
0615-8382
11-digit product format
006158382
Labeler code
0615
Product ID
0615-8382_8970ba1c-ea60-4d30-be3b-e53b1bdc7871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA212774
Marketing category
ANDA
Marketing start
2020-08-10
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
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
0615-8382-39Midodrine Hydrochloride30 in 1 BLISTER PACKTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8382MIDODRINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]5Current NDC, Legacy NDC, 1 package rows20240918_6c089bcf-c3ac-44c3-9336-8358c4d81bcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8382-390061583823930 TABLET in 1 BLISTER PACK (0615-8382-39) 30 tablet2021-02-090000-00-00NoNoCurrent