Midodrine Hydrochloride

Product NDC
67046-1512
11-digit product format
670461512
Labeler code
67046
Product ID
67046-1512_2d1b581e-1683-9af6-e063-6394a90ac136
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA217271
Marketing category
ANDA
Marketing start
2025-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Midodrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDODRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59JV96YTXV
Rxcui993470

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
67046-1512-3Midodrine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1512MIDODRINE HYDROCHLORIDE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250203_2d1b58a7-ec7f-f3ea-e063-6294a90a27fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993470midodrine HCl 5 MG Oral TabletPSN2d1b58a7-ec7f-f3ea-e063-6294a90a27fb1
993470midodrine hydrochloride 5 MG Oral TabletSCD2d1b58a7-ec7f-f3ea-e063-6294a90a27fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1512-36704615120330 TABLET in 1 BLISTER PACK (67046-1512-3) 30 tablet2025-02-01NoNoHistorical