NDC 51407-192

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 Golden State Medical Supply Inc.. The primary component is Ezetimibe; Simvastatin.

Product ID51407-192_88cd2fda-0ce0-d1e6-e053-2995a90ad24c
NDC51407-192
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe and Simvastatin
Generic NameEzetimibe And Simvastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA200909
Labeler NameGolden State Medical Supply 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 Through2020-12-31

Packaging

NDC 51407-192-05

500 TABLET in 1 BOTTLE (51407-192-05)
Marketing Start Date2019-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51407-192-90 [51407019290]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA200909
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-29

NDC 51407-192-30 [51407019230]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA200909
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-29

NDC 51407-192-05 [51407019205]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA200909
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-29

NDC 51407-192-10 [51407019210]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA200909
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-29

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:88cd0e7b-e8dc-6125-e053-2a95a90aaa27
Manufacturer
UNII

Pharmacological Class

  • Decreased Cholesterol Absorption [PE]
  • Dietary Cholesterol Absorption Inhibitor [EPC]
  • HMG-CoA Reductase Inhibitor [EPC]
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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
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