DEXTENZA is a Intracanalicular; Ophthalmic Insert in the Human Prescription Drug category. It is labeled and distributed by Ocular Therapeutix, Inc.. The primary component is Dexamethasone.
Product ID | 70382-204_58f233d6-7061-416b-a627-ac63ceb3dc8a |
NDC | 70382-204 |
Product Type | Human Prescription Drug |
Proprietary Name | DEXTENZA |
Generic Name | Dexamethasone |
Dosage Form | Insert |
Route of Administration | INTRACANALICULAR; OPHTHALMIC |
Marketing Start Date | 2019-01-07 |
Marketing Category | NDA / NDA |
Application Number | NDA208742 |
Labeler Name | Ocular Therapeutix, Inc. |
Substance Name | DEXAMETHASONE |
Active Ingredient Strength | 0 mg/1 |
Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2019-01-07 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208742 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-01-07 |
Marketing Category | NDA |
Application Number | NDA208742 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-01-07 |
Marketing Category | NDA |
Application Number | NDA208742 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-01-07 |
Marketing Category | NDA |
Application Number | NDA208742 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-01-07 |
Ingredient | Strength |
---|---|
DEXAMETHASONE | .4 mg/1 |
SPL SET ID: | 7514e6b8-c33f-4fbf-8810-ef520e1eb4bd |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
70382-204 | DEXTENZA | DEXTENZA |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DEXTENZA 87864954 not registered Live/Pending |
Ocular Therapeutix, Inc. 2018-04-05 |
DEXTENZA 86425297 5513989 Live/Registered |
Ocular Therapeutix, Inc. 2014-10-16 |