humulin r u-500

Generic: insulin human

Labeler: eli lilly and company
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name humulin r u-500
Generic Name insulin human
Labeler eli lilly and company
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin human 500 [iU]/mL

Manufacturer
Eli Lilly and Company

Identifiers & Regulatory

Product NDC 0002-8501
Product ID 0002-8501_7872727a-5d70-410a-ad64-b3b47afceb5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA018780
Listing Expiration 2026-12-31
Marketing Start 1994-03-31

Pharmacologic Class

Established (EPC)
insulin [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00028501
Hyphenated Format 0002-8501

Supplemental Identifiers

RxCUI
249220 351859 1731315 1731317
UNII
1Y17CTI5SR
NUI
M0011417 N0000175944

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 humulin r u-500 (source: ndc)
Generic Name insulin human (source: ndc)
Application Number BLA018780 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 500 [iU]/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0002-8501-01 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

insulin human (500 [iU]/mL)

Linked Drug Pages (1)

Humulin R U-500, Humulin R U-500 KwikPen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "7872727a-5d70-410a-ad64-b3b47afceb5e", "openfda": {"nui": ["M0011417", "N0000175944"], "unii": ["1Y17CTI5SR"], "rxcui": ["249220", "351859", "1731315", "1731317"], "spl_set_id": ["b60e8dd0-1d48-4dc9-87fd-e14675255e8c"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin [EPC]"], "manufacturer_name": ["Eli Lilly and Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0002-8501-01", "marketing_start_date": "19970106"}], "brand_name": "Humulin R U-500", "product_id": "0002-8501_7872727a-5d70-410a-ad64-b3b47afceb5e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin [CS]", "Insulin [EPC]"], "product_ndc": "0002-8501", "generic_name": "Insulin human", "labeler_name": "Eli Lilly and Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Humulin", "brand_name_suffix": "R U-500", "active_ingredients": [{"name": "INSULIN HUMAN", "strength": "500 [iU]/mL"}], "application_number": "BLA018780", "marketing_category": "BLA", "marketing_start_date": "19940331", "listing_expiration_date": "20261231"}