sirolimus

Generic: sirolimus

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sirolimus .5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-771
Product ID 65841-771_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201676
Listing Expiration 2026-12-31
Marketing Start 2014-01-15

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 65841771
Hyphenated Format 65841-771

Supplemental Identifiers

RxCUI
349208 360110 905158
UNII
W36ZG6FT64
NUI
N0000175550 N0000175625 N0000175624 N0000175605 N0000175076

Packaging Origin

Original Packager
true

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 ANDA201676 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65841-771-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65841-771-16)
  • 10 BLISTER PACK in 1 CARTON (65841-771-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30)
source: ndc

Packages (6)

65841-771-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01) 65841-771-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05) 65841-771-06 30 TABLET, FILM COATED in 1 BOTTLE (65841-771-06) 65841-771-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10) 65841-771-16 90 TABLET, FILM COATED in 1 BOTTLE (65841-771-16) 65841-771-77 10 BLISTER PACK in 1 CARTON (65841-771-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30)

Ingredients (1)

sirolimus (.5 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": "7e6e294d-cf29-40e2-91e1-9693fdcd6b6c", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "unii": ["W36ZG6FT64"], "rxcui": ["349208", "360110", "905158"], "spl_set_id": ["82562b68-224d-482a-b399-a89b81d5eb31"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01)", "package_ndc": "65841-771-01", "marketing_start_date": "20140115"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05)", "package_ndc": "65841-771-05", "marketing_start_date": "20140115"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65841-771-06)", "package_ndc": "65841-771-06", "marketing_start_date": "20140115"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10)", "package_ndc": "65841-771-10", "marketing_start_date": "20140115"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65841-771-16)", "package_ndc": "65841-771-16", "marketing_start_date": "20140115"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-771-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30)", "package_ndc": "65841-771-77", "marketing_start_date": "20140115"}], "brand_name": "sirolimus", "product_id": "65841-771_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c", "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": "65841-771", "generic_name": "sirolimus", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA201676", "marketing_category": "ANDA", "marketing_start_date": "20140115", "listing_expiration_date": "20261231"}