FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
0378-1902
11-digit product format
003781902
Labeler code
0378
Product ID
0378-1902_e92f278e-0a58-49e3-8fc0-3a16b8474d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076577
Marketing category
ANDA
Marketing start
2003-09-11
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
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
0378-1902-01Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1902-01EA - Each0378-1902cfb67848-27f2-4fd2-8f33-f805ea9a2ca212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDODRINE HYDROCHLORIDEACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
MIDODRINEACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
MIDODRINE HYDROCHLORIDEACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
MIDODRINE HYDROCHLORIDEACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MIDODRINEACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
MIDODRINEACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1902MIDODRINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20220930_32fad00b-7e7b-4d35-9e8b-fdc979fdb88e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993470midodrine HCl 5 MG Oral TabletPSNfd28d383-add9-42a9-ad07-4d7e89f1246013
993470midodrine hydrochloride 5 MG Oral TabletSCDfd28d383-add9-42a9-ad07-4d7e89f1246013
993462midodrine HCl 10 MG Oral TabletPSN32fad00b-7e7b-4d35-9e8b-fdc979fdb88e11
993466midodrine HCl 2.5 MG Oral TabletPSN32fad00b-7e7b-4d35-9e8b-fdc979fdb88e11
993470midodrine HCl 5 MG Oral TabletPSN32fad00b-7e7b-4d35-9e8b-fdc979fdb88e11
993462midodrine hydrochloride 10 MG Oral TabletSCD32fad00b-7e7b-4d35-9e8b-fdc979fdb88e11
993466midodrine hydrochloride 2.5 MG Oral TabletSCD32fad00b-7e7b-4d35-9e8b-fdc979fdb88e11
993470midodrine hydrochloride 5 MG Oral TabletSCD32fad00b-7e7b-4d35-9e8b-fdc979fdb88e11
993470midodrine HCl 5 MG Oral TabletPSN6ab70071-e733-44e2-bcc3-f08227901b293
993470midodrine hydrochloride 5 MG Oral TabletSCD6ab70071-e733-44e2-bcc3-f08227901b293
993466midodrine HCl 2.5 MG Oral TabletPSN6d83a423-815d-436e-a299-d2d8f7bec49e2
993470midodrine HCl 5 MG Oral TabletPSN6d83a423-815d-436e-a299-d2d8f7bec49e2
993466midodrine hydrochloride 2.5 MG Oral TabletSCD6d83a423-815d-436e-a299-d2d8f7bec49e2
993470midodrine hydrochloride 5 MG Oral TabletSCD6d83a423-815d-436e-a299-d2d8f7bec49e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1902-0100378190201100 TABLET in 1 BOTTLE, PLASTIC (0378-1902-01) 100 tablet2003-09-110000-00-00NoNoCurrent