Midodrine hydrochloride

Product NDC
68382-737
11-digit product format
683820737
Labeler code
68382
Product ID
68382-737_fe679311-db62-4004-800d-2961962340de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA213055
Marketing category
ANDA
Marketing start
2020-09-17
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
68382-737-01Midodrine hydrochloride100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-737-01EA - Each68382-73785936eac-db36-4a5c-b90f-9b4ba777c04e12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-737MIDODRINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, Legacy NDC, 1 package rows20240328_3bc97210-fa2f-4979-abdf-d92e5973e6e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN3bc97210-fa2f-4979-abdf-d92e5973e6e33
993466midodrine HCl 2.5 MG Oral TabletPSN3bc97210-fa2f-4979-abdf-d92e5973e6e33
993470midodrine HCl 5 MG Oral TabletPSN3bc97210-fa2f-4979-abdf-d92e5973e6e33
993462midodrine hydrochloride 10 MG Oral TabletSCD3bc97210-fa2f-4979-abdf-d92e5973e6e33
993466midodrine hydrochloride 2.5 MG Oral TabletSCD3bc97210-fa2f-4979-abdf-d92e5973e6e33
993470midodrine hydrochloride 5 MG Oral TabletSCD3bc97210-fa2f-4979-abdf-d92e5973e6e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-737-0168382073701100 TABLET in 1 BOTTLE (68382-737-01) 100 tablet2020-09-170000-00-00NoNoCurrent