NDC 16729-442 – Cinacalcet
Cinacalcet Hydrochloride 90 mg/1 · Tablet, Film Coated · Oral
Product NDC16729-442
Product details
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Labeler
- Accord Healthcare, Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA211892
- Marketed since
- June 16, 2020
- Listing expires
- December 31, 2026
- Pharmacologic class
- Calcium-sensing Receptor Agonist
Active ingredients
- Cinacalcet Hydrochloride 90 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 16729-442-10 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-442-10) | Jun 16, 2020 |
| 16729-442-15 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-442-15) | Jun 25, 2020 |
Recalls mentioning this NDC
- D-0032-2025 Nov 6, 2024 · Class II
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - D-0030-2025 Nov 6, 2024 · Class II
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - D-0031-2025 Nov 6, 2024 · Class II
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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