NDC 59762-1001

Sirolimus

Sirolimus

Sirolimus is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Greenstone Llc. The primary component is Sirolimus.

• Product ID: 59762-1001_26c745ce-ed4e-4b5f-9704-b6f3842c7881
• NDC: 59762-1001
• Product Type: Human Prescription Drug
• Proprietary Name: Sirolimus
• Generic Name: Sirolimus
• Dosage Form: Tablet, Sugar Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-07
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021110
• Labeler Name: Greenstone LLC
• Substance Name: SIROLIMUS
• Active Ingredient Strength: 1 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: 2019-12-31

Packaging

NDC 59762-1001-1

100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1001-1)

• Marketing Start Date: 2014-01-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59762-1001-2 [59762100102]

Sirolimus TABLET, SUGAR COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA021110
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-07
• Marketing End Date: 2014-09-17

NDC 59762-1001-1 [59762100101]

Sirolimus TABLET, SUGAR COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA021110
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-07

NDC 59762-1001-3 [59762100103]

Sirolimus TABLET, SUGAR COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA021110
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-07
• Marketing End Date: 2014-09-17

Drug Details

Active Ingredients

Ingredient	Strength
SIROLIMUS	.5 mg/1

OpenFDA Data

• SPL SET ID: 5908cd1a-fc5a-462f-99ed-1d8983e253c9
• Manufacturer:
  • Greenstone LLC
• UNII:
  • W36ZG6FT64
• RxNorm Concept Unique ID - RxCUI:
  • 905158
  • 349208
  • 360110
• UPC Code:
  • 0359762100313
  • 0359762100115
  • 0359762100214

Pharmacological Class

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

Medicade Reported Pricing

59762100101 SIROLIMUS 0.5 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
0904-7147	sirolimus	sirolimus
0904-7248	Sirolimus	Sirolimus
13668-658	Sirolimus	Sirolimus
16714-187	sirolimus	sirolimus
16714-188	sirolimus	sirolimus
16714-189	sirolimus	sirolimus
68084-956	Sirolimus	Sirolimus
68084-915	Sirolimus	Sirolimus
68382-520	sirolimus	sirolimus
70954-075	Sirolimus	Sirolimus
50268-718	Sirolimus	Sirolimus
55111-654	Sirolimus	Sirolimus
55111-653	Sirolimus	Sirolimus
59762-1002	Sirolimus	Sirolimus
59762-1003	Sirolimus	Sirolimus
59762-1001	Sirolimus	Sirolimus
65841-771	sirolimus	sirolimus
66689-347	Sirolimus	Sirolimus
59762-1205	Sirolimus	Sirolimus
69238-1594	Sirolimus	Sirolimus
60505-6197	Sirolimus	Sirolimus
68462-682	sirolimus	sirolimus
68462-684	sirolimus	sirolimus
68462-683	sirolimus	sirolimus
0008-1030	Rapamune	SIROLIMUS
0008-1040	Rapamune	SIROLIMUS
0008-1041	Rapamune	SIROLIMUS
0008-1042	Rapamune	SIROLIMUS