FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
60505-1321
11-digit product format
605051321
Labeler code
60505
Product ID
60505-1321_ef40d4d7-e3ab-70fd-f7a0-b9c02055f734
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp
Application
ANDA077746
Marketing category
ANDA
Marketing start
2006-09-12
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
60505-1321-1Midodrine Hydrochloride100 in 1 BOTTLETABLET1007
60505-1321-3Midodrine Hydrochloride30 in 1 BOTTLETABLET307
60505-1321-5Midodrine Hydrochloride500 in 1 BOTTLETABLET5007
60505-1321-8Midodrine Hydrochloride1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1321-1EA - Each60505-1321871ebe5b-6f4b-4468-936e-c2565ede2c1312012-07-24
60505-1321-8EA - Each60505-1321900576f1-7e0a-4204-8a33-244a104ecb5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
midodrine hydrochlorideACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
midodrineACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1321MIDODRINE HYDROCHLORIDE TABLET [APOTEX CORP]6Current NDC, Legacy NDC, 4 package rows20250411_aec0d2de-ce83-b7c2-5d10-740607d50521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN164dce3b-1927-497e-884a-a2c72958beb98
993466midodrine HCl 2.5 MG Oral TabletPSN164dce3b-1927-497e-884a-a2c72958beb98
993470midodrine HCl 5 MG Oral TabletPSN164dce3b-1927-497e-884a-a2c72958beb98
993462midodrine hydrochloride 10 MG Oral TabletSCD164dce3b-1927-497e-884a-a2c72958beb98
993466midodrine hydrochloride 2.5 MG Oral TabletSCD164dce3b-1927-497e-884a-a2c72958beb98
993470midodrine hydrochloride 5 MG Oral TabletSCD164dce3b-1927-497e-884a-a2c72958beb98
993462midodrine HCl 10 MG Oral TabletPSNaec0d2de-ce83-b7c2-5d10-740607d505217
993466midodrine HCl 2.5 MG Oral TabletPSNaec0d2de-ce83-b7c2-5d10-740607d505217
993470midodrine HCl 5 MG Oral TabletPSNaec0d2de-ce83-b7c2-5d10-740607d505217
993462midodrine hydrochloride 10 MG Oral TabletSCDaec0d2de-ce83-b7c2-5d10-740607d505217
993466midodrine hydrochloride 2.5 MG Oral TabletSCDaec0d2de-ce83-b7c2-5d10-740607d505217
993470midodrine hydrochloride 5 MG Oral TabletSCDaec0d2de-ce83-b7c2-5d10-740607d505217
993462midodrine HCl 10 MG Oral TabletPSN159cb0cb-4b27-4a1c-8ad4-dc93604c79c76
993466midodrine HCl 2.5 MG Oral TabletPSN159cb0cb-4b27-4a1c-8ad4-dc93604c79c76
993470midodrine HCl 5 MG Oral TabletPSN159cb0cb-4b27-4a1c-8ad4-dc93604c79c76
993462midodrine hydrochloride 10 MG Oral TabletSCD159cb0cb-4b27-4a1c-8ad4-dc93604c79c76
993466midodrine hydrochloride 2.5 MG Oral TabletSCD159cb0cb-4b27-4a1c-8ad4-dc93604c79c76
993470midodrine hydrochloride 5 MG Oral TabletSCD159cb0cb-4b27-4a1c-8ad4-dc93604c79c76
993462midodrine HCl 10 MG Oral TabletPSN1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993466midodrine HCl 2.5 MG Oral TabletPSN1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993470midodrine HCl 5 MG Oral TabletPSN1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993462midodrine hydrochloride 10 MG Oral TabletSCD1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993466midodrine hydrochloride 2.5 MG Oral TabletSCD1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993470midodrine hydrochloride 5 MG Oral TabletSCD1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993462midodrine HCl 10 MG Oral TabletPSN9106776e-601a-4e3c-e053-2995a90a54354
993466midodrine HCl 2.5 MG Oral TabletPSN9106776e-601a-4e3c-e053-2995a90a54354
993470midodrine HCl 5 MG Oral TabletPSN9106776e-601a-4e3c-e053-2995a90a54354
993462midodrine hydrochloride 10 MG Oral TabletSCD9106776e-601a-4e3c-e053-2995a90a54354
993466midodrine hydrochloride 2.5 MG Oral TabletSCD9106776e-601a-4e3c-e053-2995a90a54354
993470midodrine hydrochloride 5 MG Oral TabletSCD9106776e-601a-4e3c-e053-2995a90a54354
993470midodrine HCl 5 MG Oral TabletPSNc41f7ec2-a3d7-4ff0-b51d-feda49717e7b3
993470midodrine hydrochloride 5 MG Oral TabletSCDc41f7ec2-a3d7-4ff0-b51d-feda49717e7b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-1321-160505132101100 TABLET in 1 BOTTLE (60505-1321-1) 100 tablet2006-09-120000-00-00NoNoCurrent
60505-1321-36050513210330 TABLET in 1 BOTTLE (60505-1321-3) 30 tablet2006-09-120000-00-00NoNoCurrent
60505-1321-560505132105500 TABLET in 1 BOTTLE (60505-1321-5) 500 tablet2006-09-120000-00-00NoNoCurrent
60505-1321-8605051321081000 TABLET in 1 BOTTLE (60505-1321-8) 1000 tablet2006-09-120000-00-00NoNoCurrent