Midodrine Hydrochloride

Product NDC
72603-607
11-digit product format
726030607
Labeler code
72603
Product ID
72603-607_3370f087-6bac-2032-e063-6394a90a9a60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA212543
Marketing category
ANDA
Marketing start
2025-04-21
Substance
MIDODRINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
72603-607-01Midodrine Hydrochloride100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-607-01EA - Each72603-6073f225ff9-454b-4a13-9337-637113978e4312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-607MIDODRINE HYDROCHLORIDE TABLET [NORTHSTAR RX LLC]1Current NDC, 1 package rows20250425_b015c98f-57e6-410b-9c9d-8898aa22082a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNb015c98f-57e6-410b-9c9d-8898aa22082a1
993466midodrine HCl 2.5 MG Oral TabletPSNb015c98f-57e6-410b-9c9d-8898aa22082a1
993470midodrine HCl 5 MG Oral TabletPSNb015c98f-57e6-410b-9c9d-8898aa22082a1
993462midodrine hydrochloride 10 MG Oral TabletSCDb015c98f-57e6-410b-9c9d-8898aa22082a1
993466midodrine hydrochloride 2.5 MG Oral TabletSCDb015c98f-57e6-410b-9c9d-8898aa22082a1
993470midodrine hydrochloride 5 MG Oral TabletSCDb015c98f-57e6-410b-9c9d-8898aa22082a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-607-0172603060701100 TABLET in 1 BOTTLE (72603-607-01) 100 tablet2025-04-21NoNoCurrent