Midodrine Hydrochloride

Product NDC
42291-561
11-digit product format
422910561
Labeler code
42291
Product ID
42291-561_485ffcea-c65d-bf10-e063-6294a90a4ee1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA077746
Marketing category
ANDA
Marketing start
2017-05-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midodrine Hydrochloride
Listing expiration
2027-12-31

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
42291-561-90Midodrine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-561-90EA - Each42291-561e7c86157-4377-4ecf-8020-d55930af5c0d12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-561MIDODRINE HYDROCHLORIDE TABLET [AVKARE]4Current NDC, Legacy NDC, 1 package rows20231027_1c2e8707-550f-430f-87f3-4bb3d55f4aba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993466midodrine HCl 2.5 MG Oral TabletPSN1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993470midodrine HCl 5 MG Oral TabletPSN1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993462midodrine hydrochloride 10 MG Oral TabletSCD1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993466midodrine hydrochloride 2.5 MG Oral TabletSCD1c2e8707-550f-430f-87f3-4bb3d55f4aba5
993470midodrine hydrochloride 5 MG Oral TabletSCD1c2e8707-550f-430f-87f3-4bb3d55f4aba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-561-904229105619090 TABLET in 1 BOTTLE (42291-561-90) 90 tablet2017-05-050000-00-00NoNoCurrent