dextenza

Generic: dexamethasone

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

Drug Facts

Product Profile

Brand Name dextenza
Generic Name dexamethasone
Labeler ocular therapeutix, inc.
Dosage Form INSERT
Routes
INTRACANALICULAR OPHTHALMIC
Active Ingredients

dexamethasone .4 mg/1

Manufacturer
Ocular Therapeutix, Inc.

Identifiers & Regulatory

Product NDC 70382-204
Product ID 70382-204_ad2305a4-f888-4800-a31e-1fff3ffee20d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208742
Listing Expiration 2027-12-31
Marketing Start 2019-01-07

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 70382204
Hyphenated Format 70382-204

Supplemental Identifiers

RxCUI
2108015 2108020
UPC
0370382204885
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 dextenza (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number NDA208742 (source: ndc)
Routes
INTRACANALICULAR OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88)
  • 10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88)
  • 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88)
source: ndc

Packages (3)

70382-204-01 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88) 70382-204-10 10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88) 70382-204-99 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88)

Ingredients (1)

dexamethasone (.4 mg/1)

Linked Drug Pages (1)

DEXTENZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACANALICULAR", "OPHTHALMIC"], "spl_id": "ad2305a4-f888-4800-a31e-1fff3ffee20d", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0370382204885"], "unii": ["7S5I7G3JQL"], "rxcui": ["2108015", "2108020"], "spl_set_id": ["7514e6b8-c33f-4fbf-8810-ef520e1eb4bd"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Ocular Therapeutix, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01)  / 1 INSERT in 1 POUCH (70382-204-88)", "package_ndc": "70382-204-01", "marketing_start_date": "20190107"}, {"sample": false, "description": "10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10)  / 1 INSERT in 1 POUCH (70382-204-88)", "package_ndc": "70382-204-10", "marketing_start_date": "20190107"}, {"sample": false, "description": "1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99)  / 1 INSERT in 1 POUCH (70382-204-88)", "package_ndc": "70382-204-99", "marketing_start_date": "20190107"}], "brand_name": "DEXTENZA", "product_id": "70382-204_ad2305a4-f888-4800-a31e-1fff3ffee20d", "dosage_form": "INSERT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70382-204", "generic_name": "dexamethasone", "labeler_name": "Ocular Therapeutix, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXTENZA", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": ".4 mg/1"}], "application_number": "NDA208742", "marketing_category": "NDA", "marketing_start_date": "20190107", "listing_expiration_date": "20271231"}