Midodrine Hydrochloride

Product NDC
49884-814
11-digit product format
498840814
Labeler code
49884
Product ID
49884-814_b4a5203e-c030-4311-921d-48b17c45bc49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA207169
Marketing category
ANDA
Marketing start
2018-10-29
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
49884-814-01Midodrine Hydrochloride100 in 1 BOTTLETABLET10012
49884-814-05Midodrine Hydrochloride500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-814-01EA - Each49884-814d4b4a07e-7ad2-43bd-be57-4420f58935c512018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-814MIDODRINE HYDROCHLORIDE TABLET [ENDO USA, INC.]12Current NDC, Legacy NDC, 2 package rows20250109_863f12bd-d4a9-4547-8667-5dfa9e2ce6d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993466midodrine HCl 2.5 MG Oral TabletPSN5a6705af-bb72-4edb-863a-93a351bd6dba102
993466midodrine hydrochloride 2.5 MG Oral TabletSCD5a6705af-bb72-4edb-863a-93a351bd6dba102
993466midodrine HCl 2.5 MG Oral TabletPSN17b24a0b-03e4-4b58-87ab-3d66fec30226100
993466midodrine hydrochloride 2.5 MG Oral TabletSCD17b24a0b-03e4-4b58-87ab-3d66fec30226100
993462midodrine HCl 10 MG Oral TabletPSN863f12bd-d4a9-4547-8667-5dfa9e2ce6d112
993466midodrine HCl 2.5 MG Oral TabletPSN863f12bd-d4a9-4547-8667-5dfa9e2ce6d112
993470midodrine HCl 5 MG Oral TabletPSN863f12bd-d4a9-4547-8667-5dfa9e2ce6d112
993462midodrine hydrochloride 10 MG Oral TabletSCD863f12bd-d4a9-4547-8667-5dfa9e2ce6d112
993466midodrine hydrochloride 2.5 MG Oral TabletSCD863f12bd-d4a9-4547-8667-5dfa9e2ce6d112
993470midodrine hydrochloride 5 MG Oral TabletSCD863f12bd-d4a9-4547-8667-5dfa9e2ce6d112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-814-0149884081401100 TABLET in 1 BOTTLE (49884-814-01) 100 tablet2018-10-290000-00-00NoNoCurrent
49884-814-0549884081405500 TABLET in 1 BOTTLE (49884-814-05) 500 tablet2018-10-290000-00-00NoNoCurrent