Midodrine Hydrochloride

Product NDC
70756-010
11-digit product format
707560010
Labeler code
70756
Product ID
70756-010_e8d87cc3-32ad-45ec-9e23-9e15d92e66b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217271
Marketing category
ANDA
Marketing start
2023-11-01
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
70756-010-11Midodrine Hydrochloride100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-010-11EA - Each70756-010fc4ae992-51ae-4922-ae93-19444ef73af512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-010MIDODRINE HYDROCHLORIDE TABLET [LIFESTAR PHARMA LLC]4Current NDC, 1 package rows20231104_99d4aa03-81f7-4b43-a7b4-4ecc5ad13304.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN99d4aa03-81f7-4b43-a7b4-4ecc5ad133044
993466midodrine HCl 2.5 MG Oral TabletPSN99d4aa03-81f7-4b43-a7b4-4ecc5ad133044
993470midodrine HCl 5 MG Oral TabletPSN99d4aa03-81f7-4b43-a7b4-4ecc5ad133044
993462midodrine hydrochloride 10 MG Oral TabletSCD99d4aa03-81f7-4b43-a7b4-4ecc5ad133044
993466midodrine hydrochloride 2.5 MG Oral TabletSCD99d4aa03-81f7-4b43-a7b4-4ecc5ad133044
993470midodrine hydrochloride 5 MG Oral TabletSCD99d4aa03-81f7-4b43-a7b4-4ecc5ad133044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-010-1170756001011100 TABLET in 1 BOTTLE (70756-010-11) 100 tablet2023-11-01NoNoHistorical