sirolimus

Generic: sirolimus

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler northstar rx llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sirolimus 1 mg/mL

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 72603-409
Product ID 72603-409_848b53ea-cdb6-45f8-bc70-8600d2dd6dce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216728
Listing Expiration 2026-12-31
Marketing Start 2023-01-19

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 72603409
Hyphenated Format 72603-409

Supplemental Identifiers

RxCUI
314230
UPC
0372603409017
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 ANDA216728 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (72603-409-01) / 60 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

72603-409-01 1 BOTTLE, GLASS in 1 CARTON (72603-409-01) / 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": "848b53ea-cdb6-45f8-bc70-8600d2dd6dce", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "upc": ["0372603409017"], "unii": ["W36ZG6FT64"], "rxcui": ["314230"], "spl_set_id": ["848b53ea-cdb6-45f8-bc70-8600d2dd6dce"], "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": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (72603-409-01)  / 60 mL in 1 BOTTLE, GLASS", "package_ndc": "72603-409-01", "marketing_start_date": "20251101"}], "brand_name": "sirolimus", "product_id": "72603-409_848b53ea-cdb6-45f8-bc70-8600d2dd6dce", "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": "72603-409", "generic_name": "sirolimus", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/mL"}], "application_number": "ANDA216728", "marketing_category": "ANDA", "marketing_start_date": "20230119", "listing_expiration_date": "20261231"}