Sirolimus

Product NDC
70518-3547
11-digit product format
705183547
Labeler code
70518
Product ID
70518-3547_e9e9fe8d-e795-a14e-e053-2a95a90af132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sirolimus
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214753
Marketing category
ANDA
Marketing start
2022-09-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3547-070518354700100 POUCH in 1 BOX (70518-3547-0) > 1 TABLET in 1 POUCH (70518-3547-1) 100 pouch2022-09-300000-00-00NoNoCurrent