droxidopa

Product NDC
70436-141
11-digit product format
704360141
Labeler code
70436
Product ID
70436-141_1af8aeac-14cf-4330-bf4e-3e50348268c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA215265
Marketing category
ANDA
Marketing start
2021-11-10
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-141-06droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-141DROXIDOPA CAPSULE [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20230330_049f997b-1649-467e-bbb9-bdb991b0bc6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN049f997b-1649-467e-bbb9-bdb991b0bc6e2
1490034droxidopa 200 MG Oral CapsulePSN049f997b-1649-467e-bbb9-bdb991b0bc6e2
1490038droxidopa 300 MG Oral CapsulePSN049f997b-1649-467e-bbb9-bdb991b0bc6e2
1490026droxidopa 100 MG Oral CapsuleSCD049f997b-1649-467e-bbb9-bdb991b0bc6e2
1490034droxidopa 200 MG Oral CapsuleSCD049f997b-1649-467e-bbb9-bdb991b0bc6e2
1490038droxidopa 300 MG Oral CapsuleSCD049f997b-1649-467e-bbb9-bdb991b0bc6e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-141-067043601410690 CAPSULE in 1 BOTTLE (70436-141-06) 90 capsule2021-11-100000-00-00NoNoCurrent