Midodrine Hydrochloride

Product NDC
64980-434
11-digit product format
649800434
Labeler code
64980
Product ID
64980-434_311a8e3c-0112-4c91-a7cc-92709b41f170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207613
Marketing category
ANDA
Marketing start
2019-04-01
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
64980-434-01Midodrine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-434-01EA - Each64980-43484ebe845-ae2c-4695-8599-cfd71816034912019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-434MIDODRINE HYDROCHLORIDE TABLET [RISING PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20190401_ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993470midodrine HCl 5 MG Oral TabletPSN2be17e48-8258-4f29-914b-7f0fe9ace7a1101
993470midodrine hydrochloride 5 MG Oral TabletSCD2be17e48-8258-4f29-914b-7f0fe9ace7a1101
993462midodrine HCl 10 MG Oral TabletPSNffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e2
993466midodrine HCl 2.5 MG Oral TabletPSNffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e2
993470midodrine HCl 5 MG Oral TabletPSNffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e2
993462midodrine hydrochloride 10 MG Oral TabletSCDffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e2
993466midodrine hydrochloride 2.5 MG Oral TabletSCDffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e2
993470midodrine hydrochloride 5 MG Oral TabletSCDffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-434-0164980043401100 TABLET in 1 BOTTLE (64980-434-01) 100 tablet2019-04-010000-00-00NoNoCurrent