0378-3097 : Everolimus 5 mg Oral Tablet


NDC: 0378-3097
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Everolimus
Dosage Form: Oral Tablet
Application #: ANDA212936
Rev. Date: 


Appearance:


Markings: M;EVR5
Shapes:  Oval
Colors:  White
Size (mm): 10
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0378-3097-85: 4 BLISTER PACK IN 1 CARTON (0378‑3097‑85) > 7 TABLET IN 1 BLISTER PACK (0378‑3097‑32)

Active Ingredients:

  • Everolimus

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Butylated Hydroxytoluene
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (5 Mpa.s)
  • Hypromellose 2910 (15000 Mpa.s)
  • Hypromellose, Unspecified
  • Magnesium Stearate /

Pharmaceutical Classes:

  • Cytochrome 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]

Related Products:

Based on records with the same trade name.
  • 0378-0005 Everolimus 2 mg Oral Tablet, for Suspension by Mylan Pharmaceuticals Inc.
  • 0378-0006 Everolimus 3 mg Oral Tablet, for Suspension by Mylan Pharmaceuticals Inc.
  • 0378-0007 Everolimus 5 mg Oral Tablet, for Suspension by Mylan Pharmaceuticals Inc.
  • 0378-3096 Everolimus 2.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-3098 Everolimus 7.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-3099 Everolimus 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0054-0470 Everolimus .25 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0471 Everolimus .5 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0472 Everolimus .75 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0480 Everolimus 2.5 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0481 Everolimus 5 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0482 Everolimus 10 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0497 Everolimus 7.5 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0054-0604 Everolimus 1 mg Oral Tablet by Hikma Pharmaceuticals USA Inc.
  • 0093-7766 Everolimus 2.5 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-7767 Everolimus 5 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-7768 Everolimus 7.5 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-7769 Everolimus 10 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 49884-119 Everolimus 2.5 mg Oral Tablet by Par Pharmaceutical, Inc.
  • 49884-125 Everolimus 5 mg Oral Tablet by Par Pharmaceutical, Inc.
  • More related products ...

NDC QR Code

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NDC 0378-3097 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.