NDC 70771-1054

Cinacalcet

Cinacalcet

Cinacalcet is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Cinacalcet Hydrochloride.

• Product ID: 70771-1054_9fc580fd-c161-4f7c-bad7-3ab918c4e687
• NDC: 70771-1054
• Product Type: Human Prescription Drug
• Proprietary Name: Cinacalcet
• Generic Name: Cinacalcet
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208971
• Labeler Name: Cadila Healthcare Limited
• Substance Name: CINACALCET HYDROCHLORIDE
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70771-1054-1

100 TABLET, FILM COATED in 1 BOTTLE (70771-1054-1)

• Marketing Start Date: 2018-09-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70771-1054-9 [70771105409]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208971
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-13
• Marketing End Date: 2018-09-14

NDC 70771-1054-1 [70771105401]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208971
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-13
• Marketing End Date: 2018-09-14

NDC 70771-1054-3 [70771105403]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208971
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-13
• Marketing End Date: 2018-09-14

Drug Details

Active Ingredients

Ingredient	Strength
CINACALCET HYDROCHLORIDE	30 mg/1

OpenFDA Data

• SPL SET ID: 89a46a68-4da0-4666-8e0f-60a8a36b6107
• Manufacturer:
  • Cadila Healthcare Limited
• UNII:
  • 1K860WSG25
• RxNorm Concept Unique ID - RxCUI:
  • 432402
  • 432401
  • 432400

Pharmacological Class

• Calcium-sensing Receptor Agonist [EPC]
• Increased Calcium-sensing Receptor Sensitivity [MoA]

NDC Crossover Matching brand name "Cinacalcet" or generic name "Cinacalcet"

NDC	Brand Name	Generic Name
0378-6195	Cinacalcet	Cinacalcet
0378-6196	Cinacalcet	Cinacalcet
0378-6197	Cinacalcet	Cinacalcet
0904-7067	Cinacalcet	Cinacalcet
16714-078	Cinacalcet	Cinacalcet
16714-079	Cinacalcet	Cinacalcet
16714-080	Cinacalcet	Cinacalcet
16729-440	CINACALCET	Cinacalcet
16729-441	CINACALCET	Cinacalcet
16729-442	CINACALCET	Cinacalcet
31722-103	Cinacalcet	Cinacalcet
31722-104	Cinacalcet	Cinacalcet
31722-105	Cinacalcet	Cinacalcet
42291-459	Cinacalcet	Cinacalcet
42291-460	Cinacalcet	Cinacalcet
42291-461	Cinacalcet	Cinacalcet
42543-961	Cinacalcet	Cinacalcet
42543-962	Cinacalcet	Cinacalcet
42543-963	Cinacalcet	Cinacalcet
43598-367	Cinacalcet	Cinacalcet
43598-368	Cinacalcet	Cinacalcet
69097-410	CINACALCET	CINACALCET
69097-411	CINACALCET	CINACALCET
69097-412	CINACALCET	CINACALCET
70710-1002	Cinacalcet	Cinacalcet
70710-1000	Cinacalcet	Cinacalcet
70771-1054	Cinacalcet	Cinacalcet
70771-1055	Cinacalcet	Cinacalcet
70771-1056	Cinacalcet	Cinacalcet
70710-1001	Cinacalcet	Cinacalcet
47335-600	Cinacalcet	Cinacalcet
47335-380	Cinacalcet	Cinacalcet
47335-379	Cinacalcet	Cinacalcet
67877-504	Cinacalcet	Cinacalcet
67877-505	Cinacalcet	Cinacalcet
67877-503	Cinacalcet	Cinacalcet
65862-832	Cinacalcet	Cinacalcet
65862-831	Cinacalcet	Cinacalcet
65862-833	Cinacalcet	Cinacalcet
60687-525	Cinacalcet	Cinacalcet
76282-674	CINACALCET	CINACALCET
76282-676	CINACALCET	CINACALCET
76282-675	CINACALCET	CINACALCET
43598-369	Cinacalcet	Cinacalcet