Northera

Product NDC
67386-820
11-digit product format
673860820
Labeler code
67386
Product ID
67386-820_5e69b39c-3254-43bc-ae4d-258222a964d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Lundbeck Pharmaceuticals LLC
Application
NDA203202
Marketing category
NDA
Marketing start
2014-09-01
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
Northera
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROXIDOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ7A92W69L7
Rxcui1490026, 1490032, 1490034, 1490036, 1490038, 1490040

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67386-820-19Northera90 in 1 BOTTLECAPSULE9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67386-820-19EA - Each67386-8203f04c190-c04f-49c0-ab22-657e2fbf45de12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROXIDOPAACTIVE INGREDIENTJ7A92W69L7NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
DROXIDOPAACTIVE MOIETYJ7A92W69L7NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
GELATININACTIVE INGREDIENT2G86QN327LNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ANORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67386-820NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK PHARMACEUTICALS LLC]25Current NDC, Legacy NDC, 1 package rows20241222_2179f02c-48d7-48eb-8007-5ae43d8d16bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490034droxidopa 200 MG Oral CapsulePSN2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490038droxidopa 300 MG Oral CapsulePSN2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490032Northera 100 MG Oral CapsulePSN2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490036Northera 200 MG Oral CapsulePSN2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490040Northera 300 MG Oral CapsulePSN2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490032droxidopa 100 MG Oral Capsule [Northera]SBD2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490036droxidopa 200 MG Oral Capsule [Northera]SBD2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490040droxidopa 300 MG Oral Capsule [Northera]SBD2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490026droxidopa 100 MG Oral CapsuleSCD2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490034droxidopa 200 MG Oral CapsuleSCD2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490038droxidopa 300 MG Oral CapsuleSCD2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490032Northera 100 MG Oral CapsuleSY2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490036Northera 200 MG Oral CapsuleSY2179f02c-48d7-48eb-8007-5ae43d8d16bc26
1490040Northera 300 MG Oral CapsuleSY2179f02c-48d7-48eb-8007-5ae43d8d16bc26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67386-820-196738608201990 CAPSULE in 1 BOTTLE (67386-820-19) 90 capsule2014-09-010000-00-00NoNoCurrent