NDC 65862-831

Cinacalcet

Cinacalcet

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

• Product ID: 65862-831_0267a9d5-2a35-436b-a67e-ab7d2d0a6cfb
• NDC: 65862-831
• Product Type: Human Prescription Drug
• Proprietary Name: Cinacalcet
• Generic Name: Cinacalcet
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206125
• Labeler Name: Aurobindo Pharma 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: 2021-12-31

Packaging

NDC 65862-831-01

100 TABLET, FILM COATED in 1 BOTTLE (65862-831-01)

• Marketing Start Date: 2019-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65862-831-90 [65862083190]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206125
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-25

NDC 65862-831-01 [65862083101]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206125
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-25

NDC 65862-831-30 [65862083130]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206125
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-25

NDC 65862-831-05 [65862083105]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206125
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-25

Drug Details

Active Ingredients

Ingredient	Strength
CINACALCET HYDROCHLORIDE	30 mg/1

OpenFDA Data

• SPL SET ID: 42e99112-c402-4662-877f-9e3a84dff9f2
• Manufacturer:
  • Aurobindo Pharma 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