NDC 43598-367 – Cinacalcet
Cinacalcet Hydrochloride 30 mg/1 · Tablet · Oral
Product NDC43598-367
Product details
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Labeler
- Dr. Reddys Laboratories Inc
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA208368
- Marketed since
- September 18, 2020
- Marketing end
- November 30, 2026
- Pharmacologic class
- Calcium-sensing Receptor Agonist
Active ingredients
- Cinacalcet Hydrochloride 30 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 43598-367-05 | 500 TABLET in 1 BOTTLE (43598-367-05) | Sep 18, 2020 |
| 43598-367-30 | 30 TABLET in 1 BOTTLE (43598-367-30) | Sep 18, 2020 |
Recalls mentioning this NDC
- D-0028-2025 Nov 6, 2024 · Class II
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit - D-0027-2025 Nov 6, 2024 · Class II
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit - D-0026-2025 Nov 6, 2024 · Class II
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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