NDC 42543-962

Cinacalcet

Cinacalcet

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

Product ID42543-962_ebb3ed9d-c261-488e-97a1-940f63cd2a86
NDC42543-962
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet
Generic NameCinacalcet
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA209226
Labeler NameStrides Pharma Inc.
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42543-962-04

30 TABLET, FILM COATED in 1 BOTTLE (42543-962-04)
Marketing Start Date2020-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42543-962-04 [42543096204]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209226
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-01

Drug Details

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
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
43598-369CinacalcetCinacalcet

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.