NDC 67877-505

Cinacalcet

Cinacalcet

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

• Product ID: 67877-505_0d78fdf2-fc83-44b5-bd2c-5b3ff268242c
• NDC: 67877-505
• Product Type: Human Prescription Drug
• Proprietary Name: Cinacalcet
• Generic Name: Cinacalcet
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210570
• Labeler Name: Ascend Laboratories, LLC
• Substance Name: CINACALCET HYDROCHLORIDE
• Active Ingredient Strength: 90 mg/1
• Pharm Classes: Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 67877-505-01

100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01)

• Marketing Start Date: 2019-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67877-505-01 [67877050501]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA210570
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-18

NDC 67877-505-30 [67877050530]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA210570
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-18

NDC 67877-505-33 [67877050533]

Cinacalcet TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA210570
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-18

Drug Details

Active Ingredients

Ingredient	Strength
CINACALCET HYDROCHLORIDE	90 mg/1

OpenFDA Data

• SPL SET ID: 55f95ae0-84ac-4ae4-b7a0-7590ab919ae1
• Manufacturer:
  • Ascend Laboratories, LLC
• UNII:
  • 1K860WSG25

Pharmacological Class

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