FDA.reportPublic FDA data

Droxidopa

Product NDC
72205-072
11-digit product format
722050072
Labeler code
72205
Product ID
72205-072_e30e4875-830c-48ed-a6ee-0bddcceece84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA211741
Marketing category
ANDA
Marketing start
2021-02-19
Substance
DROXIDOPA
Active strength
100 mg/1
Pharmacologic classes
Catecholamines [CS], Increased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Droxidopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROXIDOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ7A92W69L7
Rxcui1490034, 1490038, 1490026

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
72205-072-05Droxidopa500 in 1 BOTTLECAPSULE5002
72205-072-90Droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-072-90EA - Each72205-0723bbbf22c-95ec-404c-b74c-96a99a8a217d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-072DROXIDOPA CAPSULE [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20210222_381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490034droxidopa 200 MG Oral CapsulePSN381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490038droxidopa 300 MG Oral CapsulePSN381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490026droxidopa 100 MG Oral CapsuleSCD381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490034droxidopa 200 MG Oral CapsuleSCD381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490038droxidopa 300 MG Oral CapsuleSCD381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-072-0572205007205500 CAPSULE in 1 BOTTLE (72205-072-05) 500 capsule2021-02-190000-00-00NoNoCurrent
72205-072-907220500729090 CAPSULE in 1 BOTTLE (72205-072-90) 90 capsule2021-02-190000-00-00NoNoCurrent