Midodrine Hydrochloride

Product NDC
81469-139
11-digit product format
814690139
Labeler code
81469
Product ID
81469-139_6e30fa38-fd26-4d37-a5f4-9e044c383362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
First Nation Group, LLC
Application
ANDA217271
Marketing category
ANDA
Marketing start
2025-08-13
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
81469-139-90Midodrine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81469-139-90EA - Each81469-1393f289219-bed2-4410-9e03-4b6c4051e52612025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN414cebaa-b87f-4d41-bc41-a77dcd3ea4341
993466midodrine HCl 2.5 MG Oral TabletPSN414cebaa-b87f-4d41-bc41-a77dcd3ea4341
993470midodrine HCl 5 MG Oral TabletPSN414cebaa-b87f-4d41-bc41-a77dcd3ea4341
993462midodrine hydrochloride 10 MG Oral TabletSCD414cebaa-b87f-4d41-bc41-a77dcd3ea4341
993466midodrine hydrochloride 2.5 MG Oral TabletSCD414cebaa-b87f-4d41-bc41-a77dcd3ea4341
993470midodrine hydrochloride 5 MG Oral TabletSCD414cebaa-b87f-4d41-bc41-a77dcd3ea4341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81469-139-908146901399090 TABLET in 1 BOTTLE (81469-139-90) 90 tablet2025-08-13NoNoCurrent