sirolimus

Generic: sirolimus

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sirolimus 1 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-718
Product ID 50268-718_4cb0eea7-6bbc-aef8-e063-6294a90a7887
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201578
Listing Expiration 2027-12-31
Marketing Start 2018-04-23

Pharmacologic Class

Established (EPC)
mtor inhibitor immunosuppressant [epc] kinase inhibitor [epc]
Mechanism of Action
mtor inhibitors [moa] protein kinase inhibitors [moa]
Physiologic Effect
decreased immunologic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268718
Hyphenated Format 50268-718

Supplemental Identifiers

UNII
W36ZG6FT64
NUI
N0000175550 N0000175625 N0000175624 N0000175605 N0000175076

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sirolimus (source: ndc)
Generic Name sirolimus (source: ndc)
Application Number ANDA201578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-718-13) / 1 TABLET in 1 BLISTER PACK (50268-718-11)
source: ndc

Packages (1)

50268-718-13 30 BLISTER PACK in 1 BOX (50268-718-13) / 1 TABLET in 1 BLISTER PACK (50268-718-11)

Ingredients (1)

sirolimus (1 mg/1)

Linked Drug Pages (1)

Sirolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4cb0eea7-6bbc-aef8-e063-6294a90a7887", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "unii": ["W36ZG6FT64"], "spl_set_id": ["6a85ad01-8144-4d9c-e053-2991aa0a4f85"], "pharm_class_pe": ["Decreased Immunologic Activity [PE]"], "pharm_class_epc": ["mTOR Inhibitor Immunosuppressant [EPC]", "Kinase Inhibitor [EPC]"], "pharm_class_moa": ["mTOR Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-718-13)  / 1 TABLET in 1 BLISTER PACK (50268-718-11)", "package_ndc": "50268-718-13", "marketing_start_date": "20180423"}], "brand_name": "Sirolimus", "product_id": "50268-718_4cb0eea7-6bbc-aef8-e063-6294a90a7887", "dosage_form": "TABLET", "pharm_class": ["Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "50268-718", "generic_name": "Sirolimus", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA201578", "marketing_category": "ANDA", "marketing_start_date": "20180423", "listing_expiration_date": "20271231"}