sirolimus

Generic: sirolimus

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler amneal pharmaceuticals ny llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sirolimus 1 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1594
Product ID 69238-1594_864e5959-61c6-44ff-8fe6-7a2550ba0a85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211212
Listing Expiration 2026-12-31
Marketing Start 2019-10-25

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 692381594
Hyphenated Format 69238-1594

Supplemental Identifiers

RxCUI
314230
UPC
0369238159431 0369238159462
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 ANDA211212 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

69238-1594-3 1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS

Ingredients (1)

sirolimus (1 mg/mL)

Linked Drug Pages (1)

Sirolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "864e5959-61c6-44ff-8fe6-7a2550ba0a85", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "upc": ["0369238159431", "0369238159462"], "unii": ["W36ZG6FT64"], "rxcui": ["314230"], "spl_set_id": ["a522b5e1-fe51-4eb8-9657-3b1d6af8dfd5"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 KIT (69238-1594-3)  / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6)  / 60 mL in 1 BOTTLE, GLASS", "package_ndc": "69238-1594-3", "marketing_start_date": "20191025"}], "brand_name": "Sirolimus", "product_id": "69238-1594_864e5959-61c6-44ff-8fe6-7a2550ba0a85", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "69238-1594", "generic_name": "SIrolimus", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/mL"}], "application_number": "ANDA211212", "marketing_category": "ANDA", "marketing_start_date": "20191025", "listing_expiration_date": "20261231"}