NDC 55111-653 – Sirolimus
Sirolimus 1 mg/1 · Tablet · Oral
Product NDC55111-653
Product details
- Brand name
- Sirolimus
- Generic name
- Sirolimus
- Labeler
- Dr. Reddy's Laboratories Limited
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA201578
- Marketed since
- October 27, 2014
- Listing expires
- December 31, 2026
- Pharmacologic class
- Kinase Inhibitor; mTOR Inhibitor Immunosuppressant
Active ingredients
- Sirolimus 1 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 55111-653-01 | 100 TABLET in 1 BOTTLE (55111-653-01) | Oct 27, 2014 |
| 55111-653-30 | 30 TABLET in 1 BOTTLE (55111-653-30) | Oct 27, 2014 |
Recalls mentioning this NDC
- D-0504-2024 May 29, 2024 · Class III
Failed Impurities/Degradation Specifications - D-1063-2016 Jul 13, 2016 · Class III
Failed impurities/degradation: out of specification result for impurity secorapamycin.
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