NDC 0008-1042

Rapamune

Sirolimus

Rapamune is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Sirolimus.

• Product ID: 0008-1042_2d77cb2a-e58f-4f95-a64c-d1efcc815f4a
• NDC: 0008-1042
• Product Type: Human Prescription Drug
• Proprietary Name: Rapamune
• Generic Name: Sirolimus
• Dosage Form: Tablet, Sugar Coated
• Route of Administration: ORAL
• Marketing Start Date: 2001-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021110
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: SIROLIMUS
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0008-1042-05

100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1042-05)

• Marketing Start Date: 2001-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-1042-05 [00008104205]

Rapamune TABLET, SUGAR COATED

• Marketing Category: NDA
• Application Number: NDA021110
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-07-01

Drug Details

Active Ingredients

Ingredient	Strength
SIROLIMUS	2 mg/1

OpenFDA Data

• SPL SET ID: 3275b824-3f82-4151-2ab2-0036a9ba0acc
• Manufacturer:
  • Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• UNII:
  • W36ZG6FT64
• RxNorm Concept Unique ID - RxCUI:
  • 351989
  • 314230
  • 349208
  • 404432
  • 351901
  • 905160
  • 905158
  • 360110
• UPC Code:
  • 0300081041054
  • 0300081041108
  • 0300081040057
  • 0300081042051
  • 0300081040101

Pharmacological Class

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

NDC Crossover Matching brand name "Rapamune" or generic name "Sirolimus"

NDC	Brand Name	Generic Name
0008-1030	Rapamune	SIROLIMUS
0008-1040	Rapamune	SIROLIMUS
0008-1041	Rapamune	SIROLIMUS
0008-1042	Rapamune	SIROLIMUS
0904-7147	sirolimus	sirolimus
0904-7248	Sirolimus	Sirolimus
13668-658	Sirolimus	Sirolimus
16714-187	sirolimus	sirolimus
16714-188	sirolimus	sirolimus
16714-189	sirolimus	sirolimus