Zilretta
- Product NDC
- 65250-003
- 11-digit product format
- 652500003
- Labeler code
- 65250
- Product ID
- 65250-003_7d477c22-27b0-4c00-a5c3-d9dbb2d7374a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- triamcinolone acetonide extended-release injectable suspension
- Dosage form
- KIT
- Route
- INTRA-ARTICULAR
- Labeler
- Pacira Pharmaceuticals, Inc.
- Application
- NDA208845
- Marketing category
- NDA
- Marketing start
- 2017-10-06
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zilretta
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 1947131, 1947133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65250-001-01 | Zilretta | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SUSPENSIO | 1 | 32 mg | 6 |
| 65250-003-01 | Zilretta | 1 in 1 CARTON | KIT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65250-003 | ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION) KIT [PACIRA PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250112_cd5c4673-21f2-4126-9556-da847b3a228b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65250-001-01 | 65250000101 | 1 in 1 VIAL, SINGLE-DOSE | | | | | | Historical |
| 65250-003-01 | 65250000301 | 1 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01) | 1 kit | 2017-10-06 | 0000-00-00 | No | No | Current |