59762-1001 : Sirolimus .5 mg/1 Oral Tablet, Sugar Coated


NDC: 59762-1001
Labeler: Greenstone LLC
Product Type: Human Prescription Drug
Drug Name:  Sirolimus
Dosage Form: Oral Tablet, Sugar Coated
Application #: NDA021110
Rev. Date: 


Appearance:


Markings: RAPAMUNE;05;MG
Shapes:  Triangle (3 sides)
Colors:  Brown
Size (mm): 8
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:

  • 59762-1001-1: 100 TABLET, SUGAR COATED IN 1 BOTTLE (59762‑1001‑1)
  • 59762-1001-2: 100 BLISTER PACK IN 1 CARTON (59762‑1001‑2) > 1 TABLET, SUGAR COATED IN 1 BLISTER PACK (59762‑1001‑3)

Active Ingredients:

  • Sirolimus

Dosage Strength:

  • .5 mg

Inactive Ingredients:

  • Sucrose
  • Polyethylene Glycol 8000
  • Calcium Sulfate
  • Cellulose, Microcrystalline
  • Talc
  • Titanium Dioxide
  • Magnesium Stearate
  • Povidone K29/32
  • Lactose Monohydrate
  • Poloxamer 188
  • Carnauba Wax
  • Ferric Oxide Yellow
  • .alpha.-tocopherol Acetate
  • Glyceryl Oleate

Pharmaceutical Classes:

  • Decreased Immunologic Activity [PE]
  • mTOR Inhibitor Immunosuppressant [EPC]
  • mTOR Inhibitors [MoA]
  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 59762-1002 Sirolimus 1 mg/1 Oral Tablet, Sugar Coated by Greenstone LLC
  • 59762-1003 Sirolimus 2 mg/1 Oral Tablet, Sugar Coated by Greenstone LLC
  • 59762-1205 Sirolimus 1 mg/ml Oral Solution by Greenstone LLC
  • 0904-7147 Sirolimus 1 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7248 Sirolimus 1 mg Oral Tablet by Major Pharmaceuticals
  • 13668-658 Sirolimus 1 mg/ml Oral Solution by Torrent Pharmaceuticals Limited
  • 16714-187 Sirolimus .5 mg Oral Tablet, Film Coated by Northstar Rx LLC
  • 16714-188 Sirolimus 1 mg Oral Tablet, Film Coated by Northstar Rx LLC
  • 16714-189 Sirolimus 2 mg Oral Tablet, Film Coated by Northstar Rx LLC
  • 50268-718 Sirolimus 1 mg Oral Tablet by Avpak
  • 55111-653 Sirolimus 1 mg Oral Tablet by Dr. Reddy's Laboratories Limited
  • 55111-654 Sirolimus 2 mg Oral Tablet by Dr. Reddy's Laboratories Limited
  • 60505-6197 Sirolimus 1 mg/ml Oral Solution by Apotex Corp
  • 65841-771 Sirolimus .5 mg/1 Oral Tablet, Film Coated by Cadila Healthcare Limited
  • 65841-772 Sirolimus 1 mg Oral Tablet, Film Coated by Zydus Lifesciences Limited
  • 65841-773 Sirolimus 2 mg Oral Tablet, Film Coated by Zydus Lifesciences Limited
  • 66689-347 Sirolimus 1 mg/ml Oral Solution by Vistapharm, Inc.
  • 67877-746 Sirolimus .5 mg Oral Tablet by Ascend Laboratories, LLC
  • 67877-747 Sirolimus 1 mg Oral Tablet by Ascend Laboratories, LLC
  • 67877-748 Sirolimus 2 mg Oral Tablet by Ascend Laboratories, LLC
  • More related products ...

NDC QR Code

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NDC 59762-1001 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.