NDC 49884-127

Everolimus

Everolimus

Everolimus is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Everolimus.

Product ID49884-127_131a5a57-ee0b-4ee9-9c61-9be3dcdcbb25
NDC49884-127
Product TypeHuman Prescription Drug
Proprietary NameEverolimus
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA207934
Labeler NamePar Pharmaceutical, Inc.
Substance NameEVEROLIMUS
Active Ingredient Strength8 mg/1
Pharm ClassesCytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 49884-127-91

28 BLISTER PACK in 1 CARTON (49884-127-91) > 1 TABLET in 1 BLISTER PACK (49884-127-52)
Marketing Start Date2019-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-127-91 [49884012791]

Everolimus TABLET
Marketing CategoryANDA
Application NumberANDA207934
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-10

NDC 49884-127-52 [49884012752]

Everolimus TABLET
Marketing CategoryANDA
Application NumberANDA207934
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-10

Drug Details

Active Ingredients

IngredientStrength
EVEROLIMUS7.5 mg/1

Pharmacological Class

  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • mTOR Inhibitor Immunosuppressant [EPC]
  • mTOR Inhibitors [MoA]
  • Decreased Immunologic Activity [PE]
  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • mTOR Inhibitor Immunosuppressant [EPC]
  • mTOR Inhibitors [MoA]
  • Decreased Immunologic Activity [PE]

NDC Crossover Matching brand name "Everolimus" or generic name "Everolimus"

NDCBrand NameGeneric Name
0054-0470EverolimusEverolimus
0054-0471EverolimusEverolimus
0054-0472EverolimusEverolimus
0054-0480EverolimusEverolimus
0054-0481EverolimusEverolimus
0054-0482EverolimusEverolimus
0054-0497EverolimusEverolimus
0054-0604EverolimusEverolimus
49884-119EverolimusEverolimus
49884-127EverolimusEverolimus
49884-125EverolimusEverolimus
0378-3098everolimuseverolimus
0093-7766EverolimusEverolimus
0378-3097everolimuseverolimus
0093-7767EverolimusEverolimus
0093-7768EverolimusEverolimus
0378-3096everolimuseverolimus
0078-0414Zortresseverolimus
0078-0415Zortresseverolimus
0078-0417Zortresseverolimus
0078-0422Zortresseverolimus
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