Droxidopa

Product NDC
82249-552
11-digit product format
822490552
Labeler code
82249
Product ID
82249-552_f6dce609-c7d7-48a3-83bb-32ecf00f973f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
CivicaScript LLC
Application
ANDA213911
Marketing category
ANDA
Marketing start
2025-03-03
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82249-552-90Droxidopa90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82249-552-90EA - Each82249-5525128c8c4-5674-4ab9-a4e1-8bca17d946e912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82249-552DROXIDOPA CAPSULE [CIVICASCRIPT LLC]1Current NDC, 1 package rows20250304_f6dce609-c7d7-48a3-83bb-32ecf00f973f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSNf6dce609-c7d7-48a3-83bb-32ecf00f973f1
1490034droxidopa 200 MG Oral CapsulePSNf6dce609-c7d7-48a3-83bb-32ecf00f973f1
1490038droxidopa 300 MG Oral CapsulePSNf6dce609-c7d7-48a3-83bb-32ecf00f973f1
1490026droxidopa 100 MG Oral CapsuleSCDf6dce609-c7d7-48a3-83bb-32ecf00f973f1
1490034droxidopa 200 MG Oral CapsuleSCDf6dce609-c7d7-48a3-83bb-32ecf00f973f1
1490038droxidopa 300 MG Oral CapsuleSCDf6dce609-c7d7-48a3-83bb-32ecf00f973f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82249-552-908224905529090 CAPSULE in 1 BOTTLE (82249-552-90) 90 capsule2025-03-03NoNoCurrent