Midodrine Hydrochloride

Product NDC
71335-1705
11-digit product format
713351705
Labeler code
71335
Product ID
71335-1705_2be17e48-8258-4f29-914b-7f0fe9ace7a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

openFDA Listing Details

Product ID
71335-1705_2be17e48-8258-4f29-914b-7f0fe9ace7a1
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Midodrine Hydrochloride
Generic name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Marketing start
2019-04-01
Marketing category
ANDA
Application number
ANDA207613
Pharmacologic classes
Adrenergic alpha-Agonists [MoA]; alpha-Adrenergic Agonist [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
MIDODRINE HYDROCHLORIDE5 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii59JV96YTXV
Rxcui993470
Spl Set Id2be17e48-8258-4f29-914b-7f0fe9ace7a1
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
59JV96YTXVMIDODRINE HYDROCHLORIDE43218-56-0MIDODRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1705-17133517050130 TABLET in 1 BOTTLE (71335-1705-1) 30 tablet2020-09-100000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MIDODRINE HYDROCHLORIDE TABLETS, USP 2.5 mg, 5 mg and 10 mgBryant Ranch Prepack2020-10-16HUMAN PRESCRIPTION DRUG LABEL101