sirolimus

Generic: sirolimus

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirolimus
Generic Name sirolimus
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sirolimus 1 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-915
Product ID 68084-915_3ccedad8-85eb-c609-e063-6294a90a7e2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201578
Listing Expiration 2026-12-31
Marketing Start 2015-11-05

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 68084915
Hyphenated Format 68084-915

Supplemental Identifiers

RxCUI
349208
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 ANDA201578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-915-25) / 1 TABLET in 1 BLISTER PACK (68084-915-95)
source: ndc

Packages (1)

68084-915-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-915-25) / 1 TABLET in 1 BLISTER PACK (68084-915-95)

Ingredients (1)

sirolimus (1 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": "3ccedad8-85eb-c609-e063-6294a90a7e2d", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "unii": ["W36ZG6FT64"], "rxcui": ["349208"], "spl_set_id": ["5df60452-2b16-4ce9-8c29-48798a59d718"], "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": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-915-25)  / 1 TABLET in 1 BLISTER PACK (68084-915-95)", "package_ndc": "68084-915-25", "marketing_start_date": "20151105"}], "brand_name": "Sirolimus", "product_id": "68084-915_3ccedad8-85eb-c609-e063-6294a90a7e2d", "dosage_form": "TABLET", "pharm_class": ["Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "68084-915", "generic_name": "Sirolimus", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA201578", "marketing_category": "ANDA", "marketing_start_date": "20151105", "listing_expiration_date": "20261231"}