Sirolimus

Product NDC

68084-956

11-digit product format

680840956

Labeler code

68084

Product ID

68084-956_89030640-5556-aba7-e053-2995a90ab773

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Sirolimus

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

American Health Packaging

Application

ANDA201676

Marketing category

ANDA

Marketing start

2015-03-31

Marketing end

2020-04-30

Substance

SIROLIMUS

Active strength

1 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record