NDC 71879-001

Dexycu

Dexamethasone

Dexycu is a Intraocular Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Eyepoint Pharmaceuticals Us, Inc. The primary component is Dexamethasone.

• Product ID: 71879-001_60524f04-13ae-4b19-8da0-41d141f7b574
• NDC: 71879-001
• Product Type: Human Prescription Drug
• Proprietary Name: Dexycu
• Generic Name: Dexamethasone
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAOCULAR
• Marketing Start Date: 2018-05-22
• Marketing Category: NDA / NDA
• Application Number: NDA208912
• Labeler Name: EyePoint Pharmaceuticals US, Inc
• Substance Name: DEXAMETHASONE
• Active Ingredient Strength: 517 ug/.005mL
• Pharm Classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 71879-001-01

1 VIAL, GLASS in 1 CARTON (71879-001-01) > .5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2018-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71879-001-01 [71879000101]

Dexycu INJECTION, SUSPENSION

• Marketing Category: NDA
• Application Number: NDA208912
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-11

Drug Details

Active Ingredients

Ingredient	Strength
DEXAMETHASONE	517 ug/.005mL

OpenFDA Data

• SPL SET ID: 583d70ed-bc42-465b-983d-c770db58406f
• Manufacturer:
  • EyePoint Pharmaceuticals US, Inc
• UNII:
  • 7S5I7G3JQL
• RxNorm Concept Unique ID - RxCUI:
  • 2045404
  • 2045409

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Dexycu" or generic name "Dexamethasone"

NDC	Brand Name	Generic Name
71879-001	Dexycu	Dexycu
0054-3177	Dexamethasone	Dexamethasone
0054-4179	Dexamethasone	Dexamethasone
0054-4180	Dexamethasone	Dexamethasone
0054-4181	Dexamethasone	Dexamethasone
0054-4182	Dexamethasone	Dexamethasone
0054-4183	Dexamethasone	Dexamethasone
0054-4184	Dexamethasone	Dexamethasone
0054-4186	Dexamethasone	Dexamethasone
0054-8174	Dexamethasone	Dexamethasone
0023-3348	OZURDEX	dexamethasone