FDA.reportPublic FDA data

Droxidopa

Product NDC
67877-706
11-digit product format
678770706
Labeler code
67877
Product ID
67877-706_15a3d787-2fea-4455-9932-dd2eae43ac5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA213911
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
67877-706-05Droxidopa500 in 1 BOTTLECAPSULE5005
67877-706-90Droxidopa90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-706-90EA - Each67877-70695fda34a-b5db-4f04-b749-504af477377712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-706DROXIDOPA CAPSULE [ASCEND LABORATORIES, LLC]4Current NDC, Legacy NDC, 2 package rows20220827_6091958e-f04e-47c0-9eef-9c204df4edd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN6091958e-f04e-47c0-9eef-9c204df4edd95
1490034droxidopa 200 MG Oral CapsulePSN6091958e-f04e-47c0-9eef-9c204df4edd95
1490038droxidopa 300 MG Oral CapsulePSN6091958e-f04e-47c0-9eef-9c204df4edd95
1490026droxidopa 100 MG Oral CapsuleSCD6091958e-f04e-47c0-9eef-9c204df4edd95
1490034droxidopa 200 MG Oral CapsuleSCD6091958e-f04e-47c0-9eef-9c204df4edd95
1490038droxidopa 300 MG Oral CapsuleSCD6091958e-f04e-47c0-9eef-9c204df4edd95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-706-0567877070605500 CAPSULE in 1 BOTTLE (67877-706-05) 500 capsule2021-02-190000-00-00NoNoCurrent
67877-706-906787707069090 CAPSULE in 1 BOTTLE (67877-706-90) 90 capsule2021-02-190000-00-00NoNoCurrent