lyumjev tempo pen (0002-8235)

Drug Facts

Product Profile

Brand Name lyumjev tempo pen

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 0002-8235

Product ID 0002-8235_567d0b77-239e-4a05-9d84-8364e0e1ef7a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category BLA

Application Number BLA761109

Marketing Start 2020-06-15

Marketing End 2027-11-06

Pharmacologic Class

Established (EPC)

insulin analog [epc]

Chemical Structure

insulin [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00028235

Hyphenated Format 0002-8235

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 tempo pen (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 (0002-8235-05) / 3 mL in 1 SYRINGE (0002-8235-01)
1 SYRINGE in 1 CARTON (0002-8235-99) / 3 mL in 1 SYRINGE

source: ndc

Packages (2)

0002-8235-05 5 SYRINGE in 1 CARTON (0002-8235-05) / 3 mL in 1 SYRINGE (0002-8235-01) 0002-8235-99 1 SYRINGE in 1 CARTON (0002-8235-99) / 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 (0002-8235-05)  / 3 mL in 1 SYRINGE (0002-8235-01)", "package_ndc": "0002-8235-05", "marketing_end_date": "20271106", "marketing_start_date": "20220929"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (0002-8235-99)  / 3 mL in 1 SYRINGE", "package_ndc": "0002-8235-99", "marketing_end_date": "20271106", "marketing_start_date": "20240110"}], "brand_name": "LYUMJEV Tempo Pen", "product_id": "0002-8235_567d0b77-239e-4a05-9d84-8364e0e1ef7a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [Chemical/Ingredient]"], "product_ndc": "0002-8235", "generic_name": "Insulin lispro-aabc", "labeler_name": "Eli Lilly and Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYUMJEV", "brand_name_suffix": "Tempo Pen", "active_ingredients": [{"name": "INSULIN LISPRO", "strength": "100 [iU]/mL"}], "application_number": "BLA761109", "marketing_category": "BLA", "marketing_end_date": "20271106", "marketing_start_date": "20200615"}