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NDC 70801-0003-01 Zilretta Details
Zilretta
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 Information
| NDC | 70801-0003 |
|---|---|
| Product ID | 70801-003_c6a1407e-47cb-aeb9-e053-2995a90aca58 |
| Associated GPIs | 2210005010G230 |
| GCN Sequence Number | 077804 |
| GCN Sequence Number Description | triamcinolone acetonide SUSER VIAL 32 MG INTRAARTIC |
| HIC3 | P5A |
| HIC3 Description | GLUCOCORTICOIDS |
| GCN | 43949 |
| HICL Sequence Number | 002891 |
| HICL Sequence Number Description | TRIAMCINOLONE ACETONIDE |
| Brand/Generic | Brand |
| Proprietary Name | Zilretta |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | triamcinolone acetonide extended-release injectable suspension |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | KIT |
| Route | INTRA-ARTICULAR |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Flexion Therapeutics, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208845 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 70801-0003-01 (70801000301)
| NDC Package Code | 70801-003-01 |
|---|---|
| Billing NDC | 70801000301 |
| Package | 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 |
| Marketing Start Date | 2017-10-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |