MIDODRINE HYDROCHLORIDE

Product NDC
62332-340
11-digit product format
623320340
Labeler code
62332
Product ID
62332-340_f954a150-26a9-4b64-8e86-5d5bc4eedc43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDODRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214734
Marketing category
ANDA
Marketing start
2021-01-22
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
62332-340-31MIDODRINE HYDROCHLORIDE100 in 1 BOTTLETABLET1004
62332-340-71MIDODRINE HYDROCHLORIDE500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-340-31EA - Each62332-34093a6f2cc-e204-4fae-9af3-cd78b6ab875612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-340MIDODRINE HYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20211013_873c8e29-6961-4648-bfc8-f91c2086bd94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN873c8e29-6961-4648-bfc8-f91c2086bd944
993466midodrine HCl 2.5 MG Oral TabletPSN873c8e29-6961-4648-bfc8-f91c2086bd944
993470midodrine HCl 5 MG Oral TabletPSN873c8e29-6961-4648-bfc8-f91c2086bd944
993462midodrine hydrochloride 10 MG Oral TabletSCD873c8e29-6961-4648-bfc8-f91c2086bd944
993466midodrine hydrochloride 2.5 MG Oral TabletSCD873c8e29-6961-4648-bfc8-f91c2086bd944
993470midodrine hydrochloride 5 MG Oral TabletSCD873c8e29-6961-4648-bfc8-f91c2086bd944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-340-3162332034031100 TABLET in 1 BOTTLE (62332-340-31) 100 tablet2021-01-220000-00-00NoNoCurrent
62332-340-7162332034071500 TABLET in 1 BOTTLE (62332-340-71) 500 tablet2021-01-220000-00-00NoNoCurrent