FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
71205-905
11-digit product format
712050905
Labeler code
71205
Product ID
71205-905_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
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
71205-905-00Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002
71205-905-11Midodrine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10002
71205-905-30Midodrine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
71205-905-55Midodrine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5002
71205-905-60Midodrine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
71205-905-72Midodrine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
71205-905-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-905-00EA - Each71205-905010a049e-7178-4a53-8826-4316c9dab2f012021-08-05
71205-905-11EA - Each71205-9053f405a79-52fe-450e-b1fc-d700c17eaa6312021-08-05
71205-905-30EA - Each71205-90578cd824e-cf3f-4845-87ff-2b0eca3bc56012021-08-05
71205-905-55EA - Each71205-905ad1afcbb-bf72-4ff1-b9ae-606c27e15d2912021-08-05
71205-905-60EA - Each71205-905c63aabba-2c50-4cf7-adb2-3f6049d7b3b312021-08-05
71205-905-72EA - Each71205-9053ac1e123-a286-4067-bdc2-42cc06abad4812021-08-05
71205-905-90EA - Each71205-90577807699-44d8-420d-8399-72c6d9250ccf12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-905MIDODRINE 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
71205-905-0071205090500100 TABLET in 1 BOTTLE, PLASTIC (71205-905-00) 100 tablet2021-07-200000-00-00NoNoCurrent
71205-905-11712050905111000 TABLET in 1 BOTTLE, PLASTIC (71205-905-11) 1000 tablet2021-07-200000-00-00NoNoCurrent
71205-905-307120509053030 TABLET in 1 BOTTLE, PLASTIC (71205-905-30) 30 tablet2021-07-200000-00-00NoNoCurrent
71205-905-5571205090555500 TABLET in 1 BOTTLE, PLASTIC (71205-905-55) 500 tablet2021-07-200000-00-00NoNoCurrent
71205-905-607120509056060 TABLET in 1 BOTTLE, PLASTIC (71205-905-60) 60 tablet2021-07-200000-00-00NoNoCurrent
71205-905-7271205090572120 TABLET in 1 BOTTLE, PLASTIC (71205-905-72) 120 tablet2021-07-200000-00-00NoNoCurrent
71205-905-907120509059090 TABLET in 1 BOTTLE, PLASTIC (71205-905-90) 90 tablet2021-07-200000-00-00NoNoCurrent