Droxidopa

Product NDC
70710-1391
11-digit product format
707101391
Labeler code
70710
Product ID
70710-1391_98a2a992-f0a2-47e4-91c0-bdae39b73e63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211818
Marketing category
ANDA
Marketing start
2021-02-19
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
70710-1391-9Droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1391DROXIDOPA CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 1 package rows20230921_aa3ce55a-1ea9-4b50-b682-6f25398bcc29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSNaa3ce55a-1ea9-4b50-b682-6f25398bcc292
1490034droxidopa 200 MG Oral CapsulePSNaa3ce55a-1ea9-4b50-b682-6f25398bcc292
1490038droxidopa 300 MG Oral CapsulePSNaa3ce55a-1ea9-4b50-b682-6f25398bcc292
1490026droxidopa 100 MG Oral CapsuleSCDaa3ce55a-1ea9-4b50-b682-6f25398bcc292
1490034droxidopa 200 MG Oral CapsuleSCDaa3ce55a-1ea9-4b50-b682-6f25398bcc292
1490038droxidopa 300 MG Oral CapsuleSCDaa3ce55a-1ea9-4b50-b682-6f25398bcc292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1391-97071013910990 CAPSULE in 1 BOTTLE (70710-1391-9) 90 capsule2021-02-190000-00-00NoNoCurrent