sirolimus

Generic: sirolimus

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sirolimus 1 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7248
Product ID 0904-7248_6b65f460-e55e-4196-af44-b9dd0e293e76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214753
Listing Expiration 2026-12-31
Marketing Start 2021-03-13

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 09047248
Hyphenated Format 0904-7248

Supplemental Identifiers

RxCUI
349208
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 ANDA214753 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7248-04 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "6b65f460-e55e-4196-af44-b9dd0e293e76", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "unii": ["W36ZG6FT64"], "rxcui": ["349208"], "spl_set_id": ["1bef7d8f-524b-4218-8fef-6c3f3628d33e"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7248-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7248-04", "marketing_start_date": "20220621"}], "brand_name": "Sirolimus", "product_id": "0904-7248_6b65f460-e55e-4196-af44-b9dd0e293e76", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "0904-7248", "generic_name": "Sirolimus", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA214753", "marketing_category": "ANDA", "marketing_start_date": "20210313", "listing_expiration_date": "20261231"}