sirolimus

Product NDC
0904-7147
11-digit product format
009047147
Labeler code
0904
Product ID
0904-7147_a44e8696-c6e2-41eb-9700-fa0313cc6932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sirolimus
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA208691
Marketing category
ANDA
Marketing start
2020-10-16
Marketing end
2022-11-30
Substance
SIROLIMUS
Active strength
1 mg/1
Pharmacologic classes
Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7147-070090471470730 BLISTER PACK in 1 CARTON (0904-7147-07) > 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2020-10-160000-00-00NoNoCurrent