NDC 70801-003
Zilretta
Triamcinolone Acetonide Extended-release Injectable Suspension
Zilretta is a Intra-articular Kit in the Human Prescription Drug category. It is labeled and distributed by Flexion Therapeutics, Inc.. The primary component is .
| Product ID | 70801-003_2a8c0f7c-806f-4daa-8982-4e41d8ea2e63 |
| NDC | 70801-003 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zilretta |
| Generic Name | Triamcinolone Acetonide Extended-release Injectable Suspension |
| Dosage Form | Kit |
| Route of Administration | INTRA-ARTICULAR |
| Marketing Start Date | 2017-10-06 |
| Marketing End Date | 2023-03-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208845 |
| Labeler Name | Flexion Therapeutics, Inc. |
| Active Ingredient Strength | 0 |
| NDC Exclude Flag | N |
Packaging
NDC 70801-003-01
1 KIT in 1 CARTON (70801-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (70801-001-02) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (70801-002-02) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (70801-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (70801-002-0
| Marketing Start Date | 2017-10-06 |
| Marketing End Date | 2023-03-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70801-003-02 [70801000302]
Zilretta KIT
| Marketing Category | NDA |
| Application Number | NDA208845 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-06 |
NDC 70801-003-01 [70801000301]
Zilretta KIT
| Marketing Category | NDA |
| Application Number | NDA208845 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-10-06 |
Drug Details
OpenFDA Data
| SPL SET ID: | 29aba18c-2146-429f-a47b-4b8605d48cd7 |
| Manufacturer | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Zilretta" or generic name "Triamcinolone Acetonide Extended-release Injectable Suspension"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65250-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension |
| 70801-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension |
Trademark Results [Zilretta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZILRETTA 86508900 5401949 Live/Registered |
Flexion Therapeutics, Inc. 2015-01-20 |
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