FDA.reportPublic FDA data

Droxidopa

Product NDC
50228-431
11-digit product format
502280431
Labeler code
50228
Product ID
50228-431_bbb2d8e3-70b5-78f2-e053-2995a90a285e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA214017
Marketing category
ANDA
Marketing start
2021-02-18
Substance
DROXIDOPA
Active strength
300 mg/1
Pharmacologic classes
Catecholamines [CS], Increased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Droxidopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROXIDOPA300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ7A92W69L7
Rxcui1490026, 1490034, 1490038

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60631d48-5636-440b-b5b6-ec0ca1c1ff07Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-431-05Droxidopa500 in 1 BOTTLECAPSULE5001
50228-431-30Droxidopa30 in 1 BOTTLECAPSULE301
50228-431-90Droxidopa90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-431-90EA - Each50228-431859d363e-724d-42c8-ad45-01b8f171ef7512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-431DROXIDOPA CAPSULE [SCIEGEN PHARMACEUTICALS INC]1Current NDC, Legacy NDC, 3 package rows20210220_10b02d98-ebb8-4152-bd56-3402417fbf79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN10b02d98-ebb8-4152-bd56-3402417fbf791
1490034droxidopa 200 MG Oral CapsulePSN10b02d98-ebb8-4152-bd56-3402417fbf791
1490038droxidopa 300 MG Oral CapsulePSN10b02d98-ebb8-4152-bd56-3402417fbf791
1490026droxidopa 100 MG Oral CapsuleSCD10b02d98-ebb8-4152-bd56-3402417fbf791
1490034droxidopa 200 MG Oral CapsuleSCD10b02d98-ebb8-4152-bd56-3402417fbf791
1490038droxidopa 300 MG Oral CapsuleSCD10b02d98-ebb8-4152-bd56-3402417fbf791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-431-0550228043105500 CAPSULE in 1 BOTTLE (50228-431-05) 500 capsule2021-02-180000-00-00NoNoCurrent
50228-431-305022804313030 CAPSULE in 1 BOTTLE (50228-431-30) 30 capsule2021-02-180000-00-00NoNoCurrent
50228-431-905022804319090 CAPSULE in 1 BOTTLE (50228-431-90) 90 capsule2021-02-180000-00-00NoNoCurrent