FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
71205-906
11-digit product format
712050906
Labeler code
71205
Product ID
71205-906_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
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
71205-906-00Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002
71205-906-11Midodrine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10002
71205-906-30Midodrine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
71205-906-55Midodrine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5002
71205-906-60Midodrine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
71205-906-72Midodrine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
71205-906-90Midodrine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-906-00EA - Each71205-90683248196-9153-4877-8446-6ef7d8220bce12021-08-05
71205-906-11EA - Each71205-906f859b7e0-742f-49f0-bc71-04803af0e96212021-08-05
71205-906-30EA - Each71205-906e0e70b46-cd0c-4570-8e12-3f54edd3fde312021-08-05
71205-906-55EA - Each71205-9069ced1e8a-a5c5-4c36-8516-4cace26bc22e12021-08-05
71205-906-60EA - Each71205-906e5a6a819-01ca-48f4-a63b-960e0863623612021-08-05
71205-906-72EA - Each71205-906ad59fba0-be47-4dc3-81f5-9c6cab8e54d212021-08-05
71205-906-90EA - Each71205-906f880d07d-15c9-4ece-85e4-481dd8d5dfbe12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-906MIDODRINE 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
71205-906-0071205090600100 TABLET in 1 BOTTLE, PLASTIC (71205-906-00) 100 tablet2021-07-200000-00-00NoNoCurrent
71205-906-11712050906111000 TABLET in 1 BOTTLE, PLASTIC (71205-906-11) 1000 tablet2021-07-200000-00-00NoNoCurrent
71205-906-307120509063030 TABLET in 1 BOTTLE, PLASTIC (71205-906-30) 30 tablet2021-07-200000-00-00NoNoCurrent
71205-906-5571205090655500 TABLET in 1 BOTTLE, PLASTIC (71205-906-55) 500 tablet2021-07-200000-00-00NoNoCurrent
71205-906-607120509066060 TABLET in 1 BOTTLE, PLASTIC (71205-906-60) 60 tablet2021-07-200000-00-00NoNoCurrent
71205-906-7271205090672120 TABLET in 1 BOTTLE, PLASTIC (71205-906-72) 120 tablet2021-07-200000-00-00NoNoCurrent
71205-906-907120509069090 TABLET in 1 BOTTLE, PLASTIC (71205-906-90) 90 tablet2021-07-200000-00-00NoNoCurrent