Droxidopa

Product NDC
0904-7393
11-digit product format
009047393
Labeler code
0904
Product ID
0904-7393_cf4934be-a283-4a81-9f26-3148a5e875a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS
Application
ANDA211741
Marketing category
ANDA
Marketing start
2021-02-19
Substance
DROXIDOPA
Active strength
200 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
DROXIDOPA200 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
0904-7393-89Droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7393-89EA - Each0904-739311e36fe0-2dfd-4add-9b94-d5dc8a93e7ac12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7393DROXIDOPA CAPSULE [MAJOR PHARMACEUTICALS]2Current NDC, 1 package rows20240129_04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02
1490034droxidopa 200 MG Oral CapsulePSN04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02
1490038droxidopa 300 MG Oral CapsulePSN04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02
1490026droxidopa 100 MG Oral CapsuleSCD04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02
1490034droxidopa 200 MG Oral CapsuleSCD04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02
1490038droxidopa 300 MG Oral CapsuleSCD04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7393-890090473938990 CAPSULE in 1 BOTTLE (0904-7393-89) 90 capsule2023-12-28NoNoCurrent