NDC directory

sirolimus

AvPAK · TABLET, FILM COATED

50268-827ANDADecreased Immunologic Activity [PE]
Product NDC
50268-827
Generic name
sirolimus
Labeler name
AvPAK
Brand name
sirolimus
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
TABLET, FILM COATED
SPL ID
5ed39798-4520-727d-e063-6394a90a1a26
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261027
Product ID
50268-827_5ed39798-4520-727d-e063-6394a90a1a26
Application number
ANDA201676
Brand name base
sirolimus
Active ingredients
  1. Name
    SIROLIMUS
    Strength
    .5 mg/1
Packaging
  1. Package NDC
    50268-827-13
    Description
    30 BLISTER PACK in 1 BOX (50268-827-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-827-11)
    Marketing start date
    20261027
    Sample
    false
Route
ORAL
Pharm class
Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.