DROXIDOPA

Product NDC
69452-256
11-digit product format
694520256
Labeler code
69452
Product ID
69452-256_c3cfd280-3549-b590-e053-2a95a90a5eb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DROXIDOPA
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA213033
Marketing category
ANDA
Marketing start
2021-10-01
Substance
DROXIDOPA
Active strength
100 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
DROXIDOPA100 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
69452-256-19DROXIDOPA90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-256DROXIDOPA CAPSULE [BIONPHARMA INC.]1Current NDC, Legacy NDC, 1 package rows20211002_c3cfd280-3548-b590-e053-2a95a90a5eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSNc3cfd280-3548-b590-e053-2a95a90a5eb31
1490034droxidopa 200 MG Oral CapsulePSNc3cfd280-3548-b590-e053-2a95a90a5eb31
1490038droxidopa 300 MG Oral CapsulePSNc3cfd280-3548-b590-e053-2a95a90a5eb31
1490026droxidopa 100 MG Oral CapsuleSCDc3cfd280-3548-b590-e053-2a95a90a5eb31
1490034droxidopa 200 MG Oral CapsuleSCDc3cfd280-3548-b590-e053-2a95a90a5eb31
1490038droxidopa 300 MG Oral CapsuleSCDc3cfd280-3548-b590-e053-2a95a90a5eb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-256-196945202561990 CAPSULE in 1 BOTTLE, PLASTIC (69452-256-19) 90 capsule2021-10-010000-00-00NoNoCurrent