Midodrine Hydrochloride

Product NDC
23155-971
11-digit product format
231550971
Labeler code
23155
Product ID
23155-971_4d5e3859-0e0a-810d-e063-6294a90af18c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Avet Pharmaceuticals Inc.
Application
ANDA076725
Marketing category
ANDA
Marketing start
2026-03-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midodrine Hydrochloride
Listing expiration
2027-12-31

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
23155-971-01Midodrine Hydrochloride100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN4d5e42be-3476-85d4-e063-6294a90a08651
993466midodrine HCl 2.5 MG Oral TabletPSN4d5e42be-3476-85d4-e063-6294a90a08651
993470midodrine HCl 5 MG Oral TabletPSN4d5e42be-3476-85d4-e063-6294a90a08651
993462midodrine hydrochloride 10 MG Oral TabletSCD4d5e42be-3476-85d4-e063-6294a90a08651
993466midodrine hydrochloride 2.5 MG Oral TabletSCD4d5e42be-3476-85d4-e063-6294a90a08651
993470midodrine hydrochloride 5 MG Oral TabletSCD4d5e42be-3476-85d4-e063-6294a90a08651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-971-0123155097101100 TABLET in 1 BOTTLE (23155-971-01) 100 tablet2026-03-25NoNoHistorical