DROXIDOPA

Product NDC
68180-989
11-digit product format
681800989
Labeler code
68180
Product ID
68180-989_0098094d-a0c0-4b55-9851-68aaf0109233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DROXIDOPA
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211652
Marketing category
ANDA
Marketing start
2021-09-24
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
68180-989-02DROXIDOPA500 in 1 BOTTLECAPSULE5006
68180-989-09DROXIDOPA90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-989DROXIDOPA CAPSULE [LUPIN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20231220_81b798dc-b8dc-48a5-af46-82bb55f789a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN81b798dc-b8dc-48a5-af46-82bb55f789a86
1490034droxidopa 200 MG Oral CapsulePSN81b798dc-b8dc-48a5-af46-82bb55f789a86
1490038droxidopa 300 MG Oral CapsulePSN81b798dc-b8dc-48a5-af46-82bb55f789a86
1490026droxidopa 100 MG Oral CapsuleSCD81b798dc-b8dc-48a5-af46-82bb55f789a86
1490034droxidopa 200 MG Oral CapsuleSCD81b798dc-b8dc-48a5-af46-82bb55f789a86
1490038droxidopa 300 MG Oral CapsuleSCD81b798dc-b8dc-48a5-af46-82bb55f789a86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-989-0268180098902500 CAPSULE in 1 BOTTLE (68180-989-02) 500 capsule2021-09-240000-00-00NoNoCurrent
68180-989-096818009890990 CAPSULE in 1 BOTTLE (68180-989-09) 90 capsule2021-09-240000-00-00NoNoCurrent