lyumjev kwikpen

Generic: insulin lispro-aabc

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

Drug Facts

Product Profile

Brand Name lyumjev kwikpen
Generic Name insulin lispro-aabc
Labeler eli lilly and company
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin lispro 100 [iU]/mL

Manufacturer
Eli Lilly and Company

Identifiers & Regulatory

Product NDC 0002-8207
Product ID 0002-8207_567d0b77-239e-4a05-9d84-8364e0e1ef7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761109
Listing Expiration 2026-12-31
Marketing Start 2020-06-15

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00028207
Hyphenated Format 0002-8207

Supplemental Identifiers

RxCUI
2380231 2380236 2380248 2380250 2380254 2380256 2380259 2380260 2380265 2380266 2380267 2380268
UNII
GFX7QIS1II
NUI
N0000004931 N0000175453

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 lyumjev kwikpen (source: ndc)
Generic Name insulin lispro-aabc (source: ndc)
Application Number BLA761109 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 5 SYRINGE in 1 CARTON (0002-8207-05) / 3 mL in 1 SYRINGE (0002-8207-01)
  • 1 SYRINGE in 1 CARTON (0002-8207-61) / 3 mL in 1 SYRINGE
source: ndc

Packages (2)

0002-8207-05 5 SYRINGE in 1 CARTON (0002-8207-05) / 3 mL in 1 SYRINGE (0002-8207-01) 0002-8207-61 1 SYRINGE in 1 CARTON (0002-8207-61) / 3 mL in 1 SYRINGE

Ingredients (1)

insulin lispro (100 [iU]/mL)

Linked Drug Pages (1)

LYUMJEV, LYUMJEV KwikPen, LYUMJEV Tempo Pen, LYUMJEV Junior KwikPen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "567d0b77-239e-4a05-9d84-8364e0e1ef7a", "openfda": {"nui": ["N0000004931", "N0000175453"], "unii": ["GFX7QIS1II"], "rxcui": ["2380231", "2380236", "2380248", "2380250", "2380254", "2380256", "2380259", "2380260", "2380265", "2380266", "2380267", "2380268"], "spl_set_id": ["c5a056e2-b568-4ca6-9ed8-79c010942d00"], "pharm_class_cs": ["Insulin [Chemical/Ingredient]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Eli Lilly and Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE in 1 CARTON (0002-8207-05)  / 3 mL in 1 SYRINGE (0002-8207-01)", "package_ndc": "0002-8207-05", "marketing_start_date": "20200615"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (0002-8207-61)  / 3 mL in 1 SYRINGE", "package_ndc": "0002-8207-61", "marketing_start_date": "20200615"}], "brand_name": "LYUMJEV KwikPen", "product_id": "0002-8207_567d0b77-239e-4a05-9d84-8364e0e1ef7a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [Chemical/Ingredient]"], "product_ndc": "0002-8207", "generic_name": "Insulin lispro-aabc", "labeler_name": "Eli Lilly and Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYUMJEV", "brand_name_suffix": "KwikPen", "active_ingredients": [{"name": "INSULIN LISPRO", "strength": "100 [iU]/mL"}], "application_number": "BLA761109", "marketing_category": "BLA", "marketing_start_date": "20200615", "listing_expiration_date": "20261231"}