NDC 67386-822

Northera

Droxidopa

Northera is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Droxidopa.

• Product ID: 67386-822_3db0def7-9429-4cba-855b-1c571ce65379
• NDC: 67386-822
• Product Type: Human Prescription Drug
• Proprietary Name: Northera
• Generic Name: Droxidopa
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA203202
• Labeler Name: Lundbeck Pharmaceuticals LLC
• Substance Name: DROXIDOPA
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Catecholamines [CS],Increased Blood Pressure [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 67386-822-19

90 CAPSULE in 1 BOTTLE (67386-822-19)

• Marketing Start Date: 2014-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67386-822-19 [67386082219]

Northera CAPSULE

• Marketing Category: NDA
• Application Number: NDA203202
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-01

Drug Details

Active Ingredients

Ingredient	Strength
DROXIDOPA	300 mg/1

OpenFDA Data

• SPL SET ID: 2179f02c-48d7-48eb-8007-5ae43d8d16bc
• Manufacturer:
  • Lundbeck Pharmaceuticals LLC
• UNII:
  • J7A92W69L7
• RxNorm Concept Unique ID - RxCUI:
  • 1490040
  • 1490032
  • 1490026
  • 1490036
  • 1490034
  • 1490038

Pharmacological Class

• Catecholamines [CS]
• Increased Blood Pressure [PE]

NDC Crossover Matching brand name "Northera" or generic name "Droxidopa"

NDC	Brand Name	Generic Name
67386-820	Northera	droxidopa
67386-821	Northera	droxidopa
67386-822	Northera	droxidopa
0054-0532	Droxidopa	Droxidopa
0054-0533	Droxidopa	Droxidopa
0054-0534	Droxidopa	Droxidopa
0832-0720	Droxidopa	Droxidopa
0832-0721	Droxidopa	Droxidopa
0832-0722	Droxidopa	Droxidopa
27241-199	Droxidopa	Droxidopa
27241-200	Droxidopa	Droxidopa
27241-201	Droxidopa	Droxidopa
27808-199	droxidopa	droxidopa
27808-200	droxidopa	droxidopa
27808-201	droxidopa	droxidopa
31722-010	Droxidopa	Droxidopa
31722-014	Droxidopa	Droxidopa
31722-015	Droxidopa	Droxidopa
50228-429	Droxidopa	droxidopa
50228-430	Droxidopa	droxidopa
50228-431	Droxidopa	droxidopa
59651-375	Droxidopa	Droxidopa
59651-376	Droxidopa	Droxidopa
59651-377	Droxidopa	Droxidopa
63304-086	droxidopa	droxidopa
63304-104	droxidopa	droxidopa
63304-112	droxidopa	droxidopa