FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
70700-159
11-digit product format
707000159
Labeler code
70700
Product ID
70700-159_2214523a-41b1-3644-6e7c-abc4f8b0b5cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Xiromed, LLC
Application
ANDA207849
Marketing category
ANDA
Marketing start
2020-10-15
Substance
MIDODRINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
70700-159-01Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-159MIDODRINE HYDROCHLORIDE TABLET [XIROMED, LLC]7Current NDC, Legacy NDC, 1 package rows20221117_a4332a41-2a0a-a14a-9ce5-1465f39ff725.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNdf43f108-c89c-49e7-9c1a-77a0ce9b03b5103
993462midodrine hydrochloride 10 MG Oral TabletSCDdf43f108-c89c-49e7-9c1a-77a0ce9b03b5103
993462midodrine HCl 10 MG Oral TabletPSN78446de1-81f6-4764-98f3-44b4057f2175100
993462midodrine hydrochloride 10 MG Oral TabletSCD78446de1-81f6-4764-98f3-44b4057f2175100
993462midodrine HCl 10 MG Oral TabletPSNa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993466midodrine HCl 2.5 MG Oral TabletPSNa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993470midodrine HCl 5 MG Oral TabletPSNa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993462midodrine hydrochloride 10 MG Oral TabletSCDa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993466midodrine hydrochloride 2.5 MG Oral TabletSCDa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993470midodrine hydrochloride 5 MG Oral TabletSCDa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993462midodrine HCl 10 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993466midodrine HCl 2.5 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993470midodrine HCl 5 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993462midodrine hydrochloride 10 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993466midodrine hydrochloride 2.5 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993470midodrine hydrochloride 5 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993462midodrine HCl 10 MG Oral TabletPSN0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993466midodrine HCl 2.5 MG Oral TabletPSN0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993470midodrine HCl 5 MG Oral TabletPSN0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993462midodrine hydrochloride 10 MG Oral TabletSCD0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993466midodrine hydrochloride 2.5 MG Oral TabletSCD0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993470midodrine hydrochloride 5 MG Oral TabletSCD0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-159-0170700015901100 TABLET in 1 BOTTLE, PLASTIC (70700-159-01) 100 tablet2020-10-150000-00-00NoNoCurrent