Midodrine Hydrochloride

Product NDC
0245-0212
11-digit product format
002450212
Labeler code
0245
Product ID
0245-0212_18b0b9f5-6026-479e-af12-92b0e71a9d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith laboratories, LLC
Application
ANDA076725
Marketing category
ANDA
Marketing start
2004-11-03
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
0245-0212-01Midodrine Hydrochloride100 in 1 CARTONTABLET10012
0245-0212-11Midodrine Hydrochloride100 in 1 BOTTLETABLET10012
0245-0212-89Midodrine Hydrochloride1 in 1 BLISTER PACKTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0212-01EA - Each0245-02121b7075d6-abe6-4516-b9ca-2678f0f48c5f12012-07-24
0245-0212-11EA - Each0245-0212d40986e6-b0be-485d-a839-f8fff004108512012-07-24
0245-0212-89EA - Each0245-0212ac41bd2f-977e-473b-97c5-b9805f6d180312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
midodrine hydrochlorideACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
midodrineACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
talcINACTIVE INGREDIENT7SEV7J4R1UMIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES INC.]5
midodrine hydrochlorideACTIVE INGREDIENT59JV96YTXVMIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
midodrineACTIVE MOIETY6YE7PBM15HMIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
magnesium stearateINACTIVE INGREDIENT70097M6I30MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3
talcINACTIVE INGREDIENT7SEV7J4R1UMIDODRINE HCL (MIDODRINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0212MIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]11Current NDC, Legacy NDC, 3 package rows20240606_4c3517f3-1c68-4ade-b5f1-c488a3a335c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN4c3517f3-1c68-4ade-b5f1-c488a3a335c112
993466midodrine HCl 2.5 MG Oral TabletPSN4c3517f3-1c68-4ade-b5f1-c488a3a335c112
993470midodrine HCl 5 MG Oral TabletPSN4c3517f3-1c68-4ade-b5f1-c488a3a335c112
993462midodrine hydrochloride 10 MG Oral TabletSCD4c3517f3-1c68-4ade-b5f1-c488a3a335c112
993466midodrine hydrochloride 2.5 MG Oral TabletSCD4c3517f3-1c68-4ade-b5f1-c488a3a335c112
993470midodrine hydrochloride 5 MG Oral TabletSCD4c3517f3-1c68-4ade-b5f1-c488a3a335c112
993470midodrine HCl 5 MG Oral TabletPSN24847065-0be0-46eb-a084-7e5425a8be7310
993470midodrine hydrochloride 5 MG Oral TabletSCD24847065-0be0-46eb-a084-7e5425a8be7310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-0212-0100245021201100 BLISTER PACK in 1 CARTON (0245-0212-01) / 1 TABLET in 1 BLISTER PACK (0245-0212-89) 100 blister pack2004-11-030000-00-00NoNoCurrent
0245-0212-1100245021211100 TABLET in 1 BOTTLE (0245-0212-11) 100 tablet2004-11-030000-00-00NoNoCurrent
0245-0212-89002450212891 in 1 BLISTER PACKHistorical