sirolimus

Generic: sirolimus

Labeler: vistapharm, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler vistapharm, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sirolimus 1 mg/mL

Manufacturer
VistaPharm, LLC

Identifiers & Regulatory

Product NDC 66689-347
Product ID 66689-347_909758a8-92f7-443a-bfe1-3f2f6cb98eb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211040
Listing Expiration 2027-12-31
Marketing Start 2019-01-28

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 66689347
Hyphenated Format 66689-347

Supplemental Identifiers

RxCUI
314230
UPC
0366689347028
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 ANDA211040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

66689-347-02 1 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

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": "909758a8-92f7-443a-bfe1-3f2f6cb98eb0", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "upc": ["0366689347028"], "unii": ["W36ZG6FT64"], "rxcui": ["314230"], "spl_set_id": ["19880f51-badb-4846-a02a-592a210690ab"], "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": ["VistaPharm, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 KIT (66689-347-02)  / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE", "package_ndc": "66689-347-02", "marketing_start_date": "20190128"}], "brand_name": "Sirolimus", "product_id": "66689-347_909758a8-92f7-443a-bfe1-3f2f6cb98eb0", "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": "66689-347", "generic_name": "Sirolimus", "labeler_name": "VistaPharm, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/mL"}], "application_number": "ANDA211040", "marketing_category": "ANDA", "marketing_start_date": "20190128", "listing_expiration_date": "20271231"}