NDC 0023-3348
OZURDEX
Dexamethasone
OZURDEX is a Intravitreal Implant in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Dexamethasone.
| Product ID | 0023-3348_04b2b881-a84c-417c-ba09-8a76cf46faea |
| NDC | 0023-3348 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OZURDEX |
| Generic Name | Dexamethasone |
| Dosage Form | Implant |
| Route of Administration | INTRAVITREAL |
| Marketing Start Date | 2009-09-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022315 |
| Labeler Name | Allergan, Inc. |
| Substance Name | DEXAMETHASONE |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0023-3348-07
1 POUCH in 1 CARTON (0023-3348-07) > 1 IMPLANT in 1 POUCH
| Marketing Start Date | 2009-09-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0023-3348-07 [00023334807]
OZURDEX IMPLANT
| Marketing Category | NDA |
| Application Number | NDA022315 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-09-01 |
NDC 0023-3348-08 [00023334808]
OZURDEX IMPLANT
| Marketing Category | NDA |
| Application Number | NDA022315 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-09-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DEXAMETHASONE | .7 mg/1 |
OpenFDA Data
| SPL SET ID: | 4b204f44-6e8a-4d17-803c-268f0b04679f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "OZURDEX" or generic name "Dexamethasone"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0023-3348 | OZURDEX | dexamethasone |
| 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 |
Trademark Results [OZURDEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OZURDEX 77717722 3773304 Live/Registered |
Allergan, Inc. 2009-04-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.