FDA.reportPublic FDA data

Droxidopa

Product NDC
50228-429
11-digit product format
502280429
Labeler code
50228
Product ID
50228-429_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
100 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
DROXIDOPA100 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
50228-429-10Droxidopa1000 in 1 BOTTLECAPSULE10001
50228-429-30Droxidopa30 in 1 BOTTLECAPSULE301
50228-429-90Droxidopa90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-429-90EA - Each50228-42912e4cdab-4226-4063-a22e-484f302e5af712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-429DROXIDOPA 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
50228-429-10502280429101000 CAPSULE in 1 BOTTLE (50228-429-10) 1000 capsule2021-02-180000-00-00NoNoCurrent
50228-429-305022804293030 CAPSULE in 1 BOTTLE (50228-429-30) 30 capsule2021-02-180000-00-00NoNoCurrent
50228-429-905022804299090 CAPSULE in 1 BOTTLE (50228-429-90) 90 capsule2021-02-180000-00-00NoNoCurrent