Zorvolex is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Iroko Pharmaceuticals Llc. The primary component is Diclofenac.
| Product ID | 42211-203_73b05aef-df1b-4b6c-8409-021f697deae1 |
| NDC | 42211-203 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zorvolex |
| Generic Name | Diclofenac |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-10-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204592 |
| Labeler Name | Iroko Pharmaceuticals LLC |
| Substance Name | DICLOFENAC |
| Active Ingredient Strength | 18 mg/1 |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2013-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA204592 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-10-31 |
| Marketing Category | NDA |
| Application Number | NDA204592 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-10-31 |
| Marketing Category | NDA |
| Application Number | NDA204592 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-10-31 |
| Marketing Category | NDA |
| Application Number | NDA204592 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-10-31 |
| Marketing End Date | 2013-12-17 |
| Ingredient | Strength |
|---|---|
| DICLOFENAC | 18 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42211-203 | Zorvolex | diclofenac |
| 42211-204 | Zorvolex | diclofenac |
| 69344-204 | Zorvolex | Zorvolex |
| 69344-203 | Zorvolex | Zorvolex |
| 0378-8750 | Diclofenac Sodium | diclofenac |
| 17856-0833 | Diclofenac sodium | Diclofenac |
| 42291-256 | Diclofenac sodium | Diclofenac |
| 45865-986 | Diclofenac Sodium | Diclofenac |
| 46122-711 | Diclofenac Sodium | Diclofenac |
| 50090-2787 | Diclofenac sodium | Diclofenac |
| 50090-3316 | Diclofenac Sodium | Diclofenac |
| 50090-4621 | Diclofenac sodium | Diclofenac |
| 50268-237 | Diclofenac sodium | Diclofenac |
| 50436-0833 | Diclofenac sodium | Diclofenac |
| 53149-4902 | Diclofenac Sodium | Diclofenac |
| 55700-675 | Diclofenac sodium | Diclofenac |
| 55700-735 | Diclofenac Sodium | Diclofenac |
| 57896-142 | Diclofenac Sodium | Diclofenac |
| 58602-601 | Diclofenac Sodium | Diclofenac |
| 58602-602 | Diclofenac Sodium | Diclofenac |
| 58602-603 | Diclofenac Sodium | Diclofenac |
| 63187-762 | Diclofenac sodium | Diclofenac |
| 65162-683 | Diclofenac Sodium | Diclofenac |
| 65162-833 | Diclofenac sodium | Diclofenac |
| 65162-911 | Diclofenac Sodium | Diclofenac |
| 68071-3159 | Diclofenac sodium | Diclofenac |
| 68071-4246 | Diclofenac sodium | Diclofenac |
| 68788-6831 | Diclofenac sodium | Diclofenac |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZORVOLEX 85413540 4505759 Live/Registered |
ZYLA LIFE SCIENCES US INC. 2011-09-01 |