Midodrine Hydrochloride

Product NDC
51079-453
11-digit product format
510790453
Labeler code
51079
Product ID
51079-453_3a8743bb-679f-ae20-e063-6394a90a41c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076577
Marketing category
ANDA
Marketing start
2006-09-11
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
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
51079-453-01Midodrine Hydrochloride1 in 1 BLISTER PACKTABLET113
51079-453-20Midodrine Hydrochloride100 in 1 CARTONTABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-453-01EA - Each51079-4531338f573-ba9a-4dcc-98ee-9093ab21de0c12012-07-24
51079-453-20EA - Each51079-453564e8e39-8774-4649-966e-97c86d48d24312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDODRINE HYDROCHLORIDEACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
MIDODRINEACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
MIDODRINE HYDROCHLORIDEACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
MIDODRINEACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL 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
51079-453MIDODRINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]12Current NDC, Legacy NDC, 2 package rows20231228_fd28d383-add9-42a9-ad07-4d7e89f12460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993470midodrine HCl 5 MG Oral TabletPSN66bccee4-b466-4fe9-89d6-8c9eaaa9241314
993470midodrine hydrochloride 5 MG Oral TabletSCD66bccee4-b466-4fe9-89d6-8c9eaaa9241314
993470midodrine HCl 5 MG Oral TabletPSNfd28d383-add9-42a9-ad07-4d7e89f1246013
993470midodrine hydrochloride 5 MG Oral TabletSCDfd28d383-add9-42a9-ad07-4d7e89f1246013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-453-01510790453011 in 1 BLISTER PACKHistorical
51079-453-2051079045320100 BLISTER PACK in 1 CARTON (51079-453-20) / 1 TABLET in 1 BLISTER PACK (51079-453-01) 100 blister pack2006-09-110000-00-00NoNoCurrent