ozurdex

Generic: dexamethasone

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ozurdex
Generic Name dexamethasone
Labeler allergan, inc.
Dosage Form IMPLANT
Routes
INTRAVITREAL
Active Ingredients

dexamethasone .7 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-3348
Product ID 0023-3348_758c7994-1e0f-4e0d-8781-8aa0f7086368
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022315
Listing Expiration 2027-12-31
Marketing Start 2009-09-01

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 00233348
Hyphenated Format 0023-3348

Supplemental Identifiers

RxCUI
854177 854181
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 ozurdex (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number NDA022315 (source: ndc)
Routes
INTRAVITREAL
source: ndc

Resolved Composition

Strengths
  • .7 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH
  • 1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH
source: ndc

Packages (2)

0023-3348-07 1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH 0023-3348-08 1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH

Ingredients (1)

dexamethasone (.7 mg/1)

Linked Drug Pages (1)

OZURDEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVITREAL"], "spl_id": "758c7994-1e0f-4e0d-8781-8aa0f7086368", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["854177", "854181"], "spl_set_id": ["4b204f44-6e8a-4d17-803c-268f0b04679f"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0023-3348-07)  / 1 IMPLANT in 1 POUCH", "package_ndc": "0023-3348-07", "marketing_start_date": "20090901"}, {"sample": true, "description": "1 POUCH in 1 CARTON (0023-3348-08)  / 1 IMPLANT in 1 POUCH", "package_ndc": "0023-3348-08", "marketing_start_date": "20090901"}], "brand_name": "OZURDEX", "product_id": "0023-3348_758c7994-1e0f-4e0d-8781-8aa0f7086368", "dosage_form": "IMPLANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0023-3348", "generic_name": "dexamethasone", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OZURDEX", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": ".7 mg/1"}], "application_number": "NDA022315", "marketing_category": "NDA", "marketing_start_date": "20090901", "listing_expiration_date": "20271231"}