NDC 80803-153

FYARRO

Sirolimus

FYARRO is a Intravenous Injection, Powder, Lyophilized, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Aadi Bioscience. The primary component is Sirolimus.

• Product ID: 80803-153_a47907ff-03df-475a-9f95-57230053d7ca
• NDC: 80803-153
• Product Type: Human Prescription Drug
• Proprietary Name: FYARRO
• Generic Name: Sirolimus
• Dosage Form: Injection, Powder, Lyophilized, For Suspension
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2021-11-22
• Marketing Category: NDA /
• Application Number: NDA213312
• Labeler Name: Aadi Bioscience
• Substance Name: SIROLIMUS
• Active Ingredient Strength: 5 mg/mL
• 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: 2022-12-31

Packaging

NDC 80803-153-50

1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) > 20 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2021-11-22
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "FYARRO" 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