NDC 69097-411 – Cinacalcet
Cinacalcet Hydrochloride 60 mg/1 · Tablet · Oral
Product NDC69097-411
Product details
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Labeler
- Cipla USA Inc.
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA208915
- Marketed since
- March 8, 2018
- Listing expires
- December 31, 2026
- Pharmacologic class
- Calcium-sensing Receptor Agonist
Active ingredients
- Cinacalcet Hydrochloride 60 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 69097-411-02 | 30 TABLET in 1 BOTTLE (69097-411-02) | Mar 8, 2018 |
Recalls mentioning this NDC
- D-0661-2026 Jul 8, 2026 · Class II
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - D-0676-2026 Jul 8, 2026 · Class II
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - D-0675-2026 Jul 8, 2026 · Class II
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - D-0451-2026 Apr 22, 2026 · Class II
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - D-0449-2026 Apr 22, 2026 · Class II
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - D-0450-2026 Apr 22, 2026 · Class II
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - D-0226-2026 Dec 17, 2025 · Class II
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - D-0225-2026 Dec 17, 2025 · Class II
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - D-0224-2026 Dec 17, 2025 · Class II
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Other Cinacalcet products
- 16729-440 Cinacalcet Hydrochloride 30 mg/1 · Tablet, Film Coated · Accord Healthcare, Inc.
- 16729-441 Cinacalcet Hydrochloride 60 mg/1 · Tablet, Film Coated · Accord Healthcare, Inc.
- 16729-442 Cinacalcet Hydrochloride 90 mg/1 · Tablet, Film Coated · Accord Healthcare, Inc.
- 60687-516 Cinacalcet Hydrochloride 30 mg/1 · Tablet, Film Coated · American Health Packaging
- 67877-503 Cinacalcet Hydrochloride 30 mg/1 · Tablet, Film Coated · Ascend Laboratories, LLC
- 67877-505 Cinacalcet Hydrochloride 90 mg/1 · Tablet, Film Coated · Ascend Laboratories, LLC
- 67877-504 Cinacalcet Hydrochloride 60 mg/1 · Tablet, Film Coated · Ascend Laboratories, LLC
- 84386-112 Cinacalcet Hydrochloride 60 mg/1 · Tablet, Film Coated · Aurobindo Pharma Limited
- 84386-111 Cinacalcet Hydrochloride 30 mg/1 · Tablet, Film Coated · Aurobindo Pharma Limited
- 84386-113 Cinacalcet Hydrochloride 90 mg/1 · Tablet, Film Coated · Aurobindo Pharma Limited
- 50268-188 Cinacalcet Hydrochloride 30 mg/1 · Tablet, Film Coated · AvPAK
- 63629-9606 Cinacalcet Hydrochloride 90 mg/1 · Tablet, Film Coated · Bryant Ranch Prepack