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 ID67877-505_0d78fdf2-fc83-44b5-bd2c-5b3ff268242c
NDC67877-505
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet
Generic NameCinacalcet
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA210570
Labeler NameAscend Laboratories, LLC
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength90 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 67877-505-01

100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01)
Marketing Start Date2019-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-505-01 [67877050501]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210570
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-18

NDC 67877-505-30 [67877050530]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210570
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-18

NDC 67877-505-33 [67877050533]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210570
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-18

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE90 mg/1

OpenFDA Data

SPL SET ID:55f95ae0-84ac-4ae4-b7a0-7590ab919ae1
Manufacturer
UNII

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"

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

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