FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
71205-904
11-digit product format
712050904
Labeler code
71205
Product ID
71205-904_fac1a712-e714-4137-8604-2ba0f048901c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207849
Marketing category
ANDA
Marketing start
2020-10-15
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
71205-904-00Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002
71205-904-11Midodrine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10002
71205-904-30Midodrine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
71205-904-55Midodrine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5002
71205-904-60Midodrine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
71205-904-72Midodrine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
71205-904-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-904-00EA - Each71205-90447cec68a-22da-4e07-aa36-4b700681f18d12021-08-05
71205-904-11EA - Each71205-9040247262b-5185-4647-92fc-08feb28709e912021-08-05
71205-904-30EA - Each71205-904f683598d-3c47-419e-9edf-790dca69242612021-08-05
71205-904-55EA - Each71205-9044022a8f8-9bd9-4e2b-a274-89001877a5e212021-08-05
71205-904-60EA - Each71205-9044f3511ce-d306-4853-b6ce-792522536a5a12021-08-05
71205-904-72EA - Each71205-9042e91d364-f718-4022-bd52-324f878c56be12021-08-05
71205-904-90EA - Each71205-904a54c7102-77eb-47e3-8b3e-4dfdffbe796612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-904MIDODRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 7 package rows20220419_0aebf5f9-8cfa-4b77-ba40-821ce0a2b266.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-904-0071205090400100 TABLET in 1 BOTTLE, PLASTIC (71205-904-00) 100 tablet2021-07-200000-00-00NoNoCurrent
71205-904-11712050904111000 TABLET in 1 BOTTLE, PLASTIC (71205-904-11) 1000 tablet2021-07-200000-00-00NoNoCurrent
71205-904-307120509043030 TABLET in 1 BOTTLE, PLASTIC (71205-904-30) 30 tablet2021-07-200000-00-00NoNoCurrent
71205-904-5571205090455500 TABLET in 1 BOTTLE, PLASTIC (71205-904-55) 500 tablet2021-07-200000-00-00NoNoCurrent
71205-904-607120509046060 TABLET in 1 BOTTLE, PLASTIC (71205-904-60) 60 tablet2021-07-200000-00-00NoNoCurrent
71205-904-7271205090472120 TABLET in 1 BOTTLE, PLASTIC (71205-904-72) 120 tablet2021-07-200000-00-00NoNoCurrent
71205-904-907120509049090 TABLET in 1 BOTTLE, PLASTIC (71205-904-90) 90 tablet2021-07-200000-00-00NoNoCurrent