dexycu

Generic: dexamethasone

Labeler: eyepoint pharmaceuticals us, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexycu
Generic Name dexamethasone
Labeler eyepoint pharmaceuticals us, inc
Dosage Form INJECTION, SUSPENSION
Routes
INTRAOCULAR
Active Ingredients

dexamethasone 517 ug/.005mL

Manufacturer
EyePoint Pharmaceuticals US, Inc

Identifiers & Regulatory

Product NDC 71879-001
Product ID 71879-001_44fdffcc-1f20-6598-e063-6294a90aba36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208912
Listing Expiration 2026-12-31
Marketing Start 2018-05-22

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71879001
Hyphenated Format 71879-001

Supplemental Identifiers

RxCUI
2045404 2045409
UNII
7S5I7G3JQL
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dexycu (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number NDA208912 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • 517 ug/.005mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (71879-001-01) / .5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

dexamethasone (517 ug/.005mL)

Linked Drug Pages (1)

Dexycu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAOCULAR"], "spl_id": "44fdffcc-1f20-6598-e063-6294a90aba36", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["2045404", "2045409"], "spl_set_id": ["583d70ed-bc42-465b-983d-c770db58406f"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["EyePoint Pharmaceuticals US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (71879-001-01)  / .5 mL in 1 VIAL, GLASS", "package_ndc": "71879-001-01", "marketing_start_date": "20180522"}], "brand_name": "Dexycu", "product_id": "71879-001_44fdffcc-1f20-6598-e063-6294a90aba36", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71879-001", "generic_name": "dexamethasone", "labeler_name": "EyePoint Pharmaceuticals US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexycu", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "517 ug/.005mL"}], "application_number": "NDA208912", "marketing_category": "NDA", "marketing_start_date": "20180522", "listing_expiration_date": "20261231"}