Droxidopa

Product NDC
59651-377
11-digit product format
596510377
Labeler code
59651
Product ID
59651-377_eb94f573-c790-4392-95a4-ff99a81a181f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214387
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-377-90Droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-377-90EA - Each59651-377f33ecad4-0105-4c5d-8cb2-4a98e5d942e112021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-377DROXIDOPA CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 1 package rows20210504_ff263c9a-3db2-45ac-9ba6-8fca47199604.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSNff263c9a-3db2-45ac-9ba6-8fca471996042
1490034droxidopa 200 MG Oral CapsulePSNff263c9a-3db2-45ac-9ba6-8fca471996042
1490038droxidopa 300 MG Oral CapsulePSNff263c9a-3db2-45ac-9ba6-8fca471996042
1490026droxidopa 100 MG Oral CapsuleSCDff263c9a-3db2-45ac-9ba6-8fca471996042
1490034droxidopa 200 MG Oral CapsuleSCDff263c9a-3db2-45ac-9ba6-8fca471996042
1490038droxidopa 300 MG Oral CapsuleSCDff263c9a-3db2-45ac-9ba6-8fca471996042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-377-905965103779090 CAPSULE in 1 BOTTLE (59651-377-90) 90 capsule2021-02-180000-00-00NoNoCurrent