NDC 65250-003 – Zilretta
· Kit · Intra-articular
Product NDC65250-003
Product details
- Brand name
- Zilretta
- Generic name
- triamcinolone acetonide extended-release injectable suspension
- Labeler
- Pacira Pharmaceuticals, Inc.
- Dosage form
- Kit
- Route
- Intra-articular
- Marketing category
- NDA · NDA208845
- Marketed since
- October 6, 2017
- Listing expires
- December 31, 2027
Active ingredients
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 65250-003-01 | 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) | Oct 6, 2017 |
Recalls mentioning this NDC
- D-0567-2024 Jul 3, 2024 · Class II
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C - D-0546-2024 Jun 19, 2024 · Class II
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.