NDC 45963-567

Ezetimibe and Simvastatin

Ezetimibe And Simvastatin

Ezetimibe and Simvastatin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Ezetimibe; Simvastatin.

Product ID45963-567_0cbbf63e-8bda-4147-8b9e-ca74b1716ad3
NDC45963-567
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe and Simvastatin
Generic NameEzetimibe And Simvastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-26
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA202968
Labeler NameActavis Pharma, Inc.
Substance NameEZETIMIBE; SIMVASTATIN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesDecreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 45963-567-08

90 TABLET in 1 BOTTLE (45963-567-08)
Marketing Start Date2017-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-567-05 [45963056705]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA202968
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26
Marketing End Date2017-04-26

NDC 45963-567-32 [45963056732]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA202968
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26
Marketing End Date2017-04-26

NDC 45963-567-08 [45963056708]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA202968
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-26

NDC 45963-567-30 [45963056730]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA202968
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-26

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

Medicade Reported Pricing

45963056730 EZETIMIBE-SIMVASTATIN 10-40 MG

Pricing Unit: EA | Drug Type:

45963056708 EZETIMIBE-SIMVASTATIN 10-40 MG

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Ezetimibe and Simvastatin" or generic name "Ezetimibe And Simvastatin"

NDCBrand NameGeneric Name
0115-1385Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
0115-1386Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
0115-1387Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
0115-1388Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
16714-778ezetimibe and simvastatinezetimibe and simvastatin
16714-779ezetimibe and simvastatinezetimibe and simvastatin
16714-780ezetimibe and simvastatinezetimibe and simvastatin
16714-781ezetimibe and simvastatinezetimibe and simvastatin
42291-078Ezetimibe and SimvastatinEzetimibe and Simvastatin
42291-079Ezetimibe and SimvastatinEzetimibe and Simvastatin
42291-080Ezetimibe and SimvastatinEzetimibe and Simvastatin
42291-081Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-583Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-584Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-585Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-586Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-742Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-743Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-744Ezetimibe and SimvastatinEzetimibe and Simvastatin
43598-745Ezetimibe and SimvastatinEzetimibe and Simvastatin
45963-565Ezetimibe and SimvastatinEzetimibe and Simvastatin
67877-507Ezetimibe and SimvastatinEzetimibe and Simvastatin
67877-508Ezetimibe and SimvastatinEzetimibe and Simvastatin
67877-509Ezetimibe and SimvastatinEzetimibe and Simvastatin
67877-510Ezetimibe and SimvastatinEzetimibe and Simvastatin
69238-1155Ezetimibe and SimvastatinEzetimibe and Simvastatin
69238-1156Ezetimibe and SimvastatinEzetimibe and Simvastatin
69238-1158Ezetimibe and SimvastatinEzetimibe and Simvastatin
69238-1157Ezetimibe and SimvastatinEzetimibe and Simvastatin
70518-1955Ezetimibe and SimvastatinEzetimibe and Simvastatin
70518-1850Ezetimibe and SimvastatinEzetimibe and Simvastatin
45963-567Ezetimibe and SimvastatinEzetimibe and Simvastatin
45963-566Ezetimibe and SimvastatinEzetimibe and Simvastatin
45963-568Ezetimibe and SimvastatinEzetimibe and Simvastatin
50090-3479Ezetimibe and SimvastatinEzetimibe and Simvastatin
50090-3486Ezetimibe and SimvastatinEzetimibe and Simvastatin
50090-3984Ezetimibe and SimvastatinEzetimibe and Simvastatin
60429-881Ezetimibe and SimvastatinEzetimibe and Simvastatin
60429-882Ezetimibe and SimvastatinEzetimibe and Simvastatin
60429-880Ezetimibe and SimvastatinEzetimibe and Simvastatin
60429-879Ezetimibe and SimvastatinEzetimibe and Simvastatin
62559-702Ezetimibe and SimvastatinEzetimibe and Simvastatin
62559-700Ezetimibe and SimvastatinEzetimibe and Simvastatin
62559-703Ezetimibe and SimvastatinEzetimibe and Simvastatin
62559-701Ezetimibe and SimvastatinEzetimibe and Simvastatin
51407-190Ezetimibe and SimvastatinEzetimibe and Simvastatin
51407-193Ezetimibe and SimvastatinEzetimibe and Simvastatin
51407-191Ezetimibe and SimvastatinEzetimibe and Simvastatin
51407-192Ezetimibe and SimvastatinEzetimibe and Simvastatin
68462-322ezetimibe and simvastatinezetimibe and simvastatin
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.