FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
0904-6818
11-digit product format
009046818
Labeler code
0904
Product ID
0904-6818_ead857d5-e960-4309-83f4-d9537cd32b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077746
Marketing category
ANDA
Marketing start
2006-09-12
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
0904-6818-06Midodrine Hydrochloride1 in 1 BLISTER PACKTABLET18
0904-6818-06Midodrine Hydrochloride50 in 1 CARTONTABLET508
0904-6818-61Midodrine Hydrochloride1 in 1 BLISTER PACKTABLET18
0904-6818-61Midodrine Hydrochloride100 in 1 CARTONTABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6818-06EA - Each0904-68189c979400-98a1-47da-b502-f06b00e755a712021-09-07
0904-6818-61EA - Each0904-6818c6b66441-7254-44c4-98fd-0091d81f495912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6818MIDODRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 4 package rows20250216_164dce3b-1927-497e-884a-a2c72958beb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN164dce3b-1927-497e-884a-a2c72958beb98
993466midodrine HCl 2.5 MG Oral TabletPSN164dce3b-1927-497e-884a-a2c72958beb98
993470midodrine HCl 5 MG Oral TabletPSN164dce3b-1927-497e-884a-a2c72958beb98
993462midodrine hydrochloride 10 MG Oral TabletSCD164dce3b-1927-497e-884a-a2c72958beb98
993466midodrine hydrochloride 2.5 MG Oral TabletSCD164dce3b-1927-497e-884a-a2c72958beb98
993470midodrine hydrochloride 5 MG Oral TabletSCD164dce3b-1927-497e-884a-a2c72958beb98
993462midodrine HCl 10 MG Oral TabletPSN5e2443c2-f714-4b1d-bf2d-22742f4119616
993470midodrine HCl 5 MG Oral TabletPSN5e2443c2-f714-4b1d-bf2d-22742f4119616
993462midodrine hydrochloride 10 MG Oral TabletSCD5e2443c2-f714-4b1d-bf2d-22742f4119616
993470midodrine hydrochloride 5 MG Oral TabletSCD5e2443c2-f714-4b1d-bf2d-22742f4119616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6818-060090468180650 BLISTER PACK in 1 CARTON (0904-6818-06) / 1 TABLET in 1 BLISTER PACK50 blister pack2006-09-120000-00-00NoNoCurrent
0904-6818-6100904681861100 BLISTER PACK in 1 CARTON (0904-6818-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2006-09-120000-00-00NoNoCurrent