sirolimus

Generic: sirolimus

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sirolimus .5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4376
Product ID 70518-4376_38c957b7-27e3-d35c-e063-6294a90aa511
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201676
Listing Expiration 2026-12-31
Marketing Start 2025-06-28

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 705184376
Hyphenated Format 70518-4376

Supplemental Identifiers

RxCUI
905158
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 ANDA201676 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4376-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4376-1)
source: ndc

Packages (1)

70518-4376-0 100 POUCH in 1 BOX (70518-4376-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4376-1)

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": "38c957b7-27e3-d35c-e063-6294a90aa511", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "unii": ["W36ZG6FT64"], "rxcui": ["905158"], "spl_set_id": ["09f24e7a-0bea-4e02-b557-c60eb842d41a"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4376-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-4376-1)", "package_ndc": "70518-4376-0", "marketing_start_date": "20250628"}], "brand_name": "sirolimus", "product_id": "70518-4376_38c957b7-27e3-d35c-e063-6294a90aa511", "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": "70518-4376", "generic_name": "sirolimus", "labeler_name": "REMEDYREPACK INC.", "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": "20250628", "listing_expiration_date": "20261231"}