humalog tempo pen (0002-8208)

Drug Facts

Product Profile

Brand Name humalog tempo pen

Generic Name insulin lispro

Labeler eli lilly and company

Dosage Form INJECTION, SOLUTION

Routes

SUBCUTANEOUS

Active Ingredients

insulin lispro 200 [iU]/mL

Manufacturer

Eli Lilly and Company

Identifiers & Regulatory

Product NDC 0002-8208

Product ID 0002-8208_3d52c48f-89cd-4d3d-8db6-1789e76a1c79

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category BLA

Application Number BLA205747

Listing Expiration 2026-12-31

Marketing Start 2015-05-26

Pharmacologic Class

Established (EPC)

insulin analog [epc]

Chemical Structure

insulin [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00028208

Hyphenated Format 0002-8208

Supplemental Identifiers

RxCUI

242120 865098 1652239 1652242 1652639 1652640 1652644 1652646 1926331 1926332 2621571 2621572

UNII

059QF0KO0R 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 humalog tempo pen (source: ndc)

Generic Name insulin lispro (source: ndc)

Application Number BLA205747 (source: ndc)

Routes

SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

200 [iU]/mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied HUMALOG (insulin lispro) injection is a clear and colorless solution available as: a Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. HUMALOG Total Volume Concentration NDC Number Package Size U-100 multiple-dose vial 10 mL 100 units/mL 0002-7510-01 1 vial U-100 multiple-dose vial 3 mL 100 units/mL 0002-7510-17 1 vial U-100 multiple-dose vial 3 mL 100 units/mL 0002-7533-01 1 vial U-100 single-patient-use cartridge 1 3 mL 100 units/mL 0002-7516-59 5 cartridges U-100 single-patient-use KwikPen 3 mL 100 units/mL 0002-8799-59 5 pens U-100 single-patient-use Tempo Pen a 3 mL 100 units/mL 0002-8213-05 5 pens U-100 single-patient-use Junior KwikPen 3 mL 100 units/mL 0002-7714-59 5 pens U-200 single-patient-use KwikPen 3 mL 200 units/mL 0002-7712-27 2 pens U-200 single-patient-use Tempo Pen a 3 mL 200 units/mL 0002-8208-27 2 pens The U-100 KwikPen, U-100 Tempo Pen, U-200 KwikPen, and U-200 Tempo Pen dial in 1-unit increments. The U-100 Junior KwikPen dials in 0.5-unit increments. Each prefilled pen, cartridge, and reusable pen compatible with Lilly 3 mL cartridges is for single-patient-use only. HUMALOG prefilled pens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using HUMALOG vials must never share needles or syringes with another person. 16.2 Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from direct heat and light. Do not freeze and do not use if it has been frozen. See table below for storage information: * When stored at room temperature, HUMALOG U-100 and U-200 can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time. Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) In-Use (Opened) (see temperature below) HUMALOG U-100* 10 mL multiple-dose vial 28 days Until expiration date 28 days Refrigerated or room temperature. 3 mL multiple-dose vial 28 days Until expiration date 28 days Refrigerated or room temperature. 3 mL single-patient-use cartridge 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Humalog KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Humalog Tempo Pen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Humalog Junior KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) HUMALOG U-200* 3 mL single-patient-use Humalog KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Humalog Tempo Pen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) Use in an External Insulin Pump — Change the HUMALOG U-100 in the reservoir at least every 7 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C). Storage of Diluted HUMALOG U-100 for Subcutaneous Injection — Diluted HUMALOG for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )]. Do not dilute HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump. Storage of Intravenous Infusion Preparations with HUMALOG U-100 Intravenous infusion bags prepared with HUMALOG U-100 may be stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C). The prepared intravenous infusions bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .
16.1 How Supplied HUMALOG (insulin lispro) injection is a clear and colorless solution available as: a Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. HUMALOG Total Volume Concentration NDC Number Package Size U-100 multiple-dose vial 10 mL 100 units/mL 0002-7510-01 1 vial U-100 multiple-dose vial 3 mL 100 units/mL 0002-7510-17 1 vial U-100 multiple-dose vial 3 mL 100 units/mL 0002-7533-01 1 vial U-100 single-patient-use cartridge 1 3 mL 100 units/mL 0002-7516-59 5 cartridges U-100 single-patient-use KwikPen 3 mL 100 units/mL 0002-8799-59 5 pens U-100 single-patient-use Tempo Pen a 3 mL 100 units/mL 0002-8213-05 5 pens U-100 single-patient-use Junior KwikPen 3 mL 100 units/mL 0002-7714-59 5 pens U-200 single-patient-use KwikPen 3 mL 200 units/mL 0002-7712-27 2 pens U-200 single-patient-use Tempo Pen a 3 mL 200 units/mL 0002-8208-27 2 pens The U-100 KwikPen, U-100 Tempo Pen, U-200 KwikPen, and U-200 Tempo Pen dial in 1-unit increments. The U-100 Junior KwikPen dials in 0.5-unit increments. Each prefilled pen, cartridge, and reusable pen compatible with Lilly 3 mL cartridges is for single-patient-use only. HUMALOG prefilled pens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using HUMALOG vials must never share needles or syringes with another person.
PACKAGE CARTON – HUMALOG 10 mL vial NDC 0002-7510-01 Humalog ® (insulin lispro) injection 100 units per mL (U-100) For subcutaneous or intravenous use 10 mL multiple-dose vial Use only with a U-100 syringe Rx only www.humalog.com Lilly PACKAGE CARTON – HUMALOG 10 mL vial 1ct
PACKAGE CARTON – HUMALOG 3 mL vial NDC 0002-7533-01 Humalog ® (insulin lispro) injection 100 units per mL (U-100) For subcutaneous or intravenous use 3 mL multiple-dose vial Use only with a U-100 syringe Rx only www.humalog.com Lilly PACKAGE CARTON – HUMALOG 3 mL vial 1ct
PACKAGE CARTON – HUMALOG KwikPen NDC 0002-8799-59 Humalog KwikPen ® (insulin lispro) injection For Single Patient Use Only Dispense in this sealed carton. Needles not included 100 units per mL (U-100) This device is recommended for use with Becton, Dickinson and Company's insulin pen needles For subcutaneous use only. prefilled insulin delivery device Rx only 5 x 3 mL Prefilled Pens Read Insulin Delivery Device Instructions for Use PACKAGE CARTON – HUMALOG KwikPen 5ct
PACKAGE CARTON – HUMALOG Cartridge 3mL NDC 0002-7516-59 Rx only 5 x 3 mL Cartridges Humalog ® (insulin lispro) injection For Single Patient Use Only 100 units per mL (U-100) For subcutaneous use only. For use in Eli Lilly and Company's HumaPen ® LUXURA ® HD insulin delivery device. www.humalog.com Lilly PACKAGE CARTON – HUMALOG Cartridge 5ct x 3 mL
PACKAGE CARTON – HUMALOG Junior KwikPen Dispense in this sealed carton. NDC 0002-7714-59 Humalog ® Junior KwikPen ® (insulin lispro) injection For Single Patient Use Only 100 units per mL (U-100) The pen can deliver 0.5 (½) to 30 units in one injection. 5 x 3 mL prefilled pens For subcutaneous use only. prefilled insulin delivery device Rx only Read Humalog ® Junior KwikPen ® Instructions for Use. NEEDLES NOT INCLUDED This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. Lilly PACKAGE CARTON – HUMALOG Junior KwikPen
PACKAGE CARTON – HUMALOG Tempo Pen NDC 0002-8213-05 Humalog ® Tempo Pen TM (insulin lispro) injection For Single Patient Use Only Dispense in this sealed carton. Needles not included 100 units per mL (U-100) This device is recommended for use with Becton, Dickinson and Company's insulin pen needles For subcutaneous use only. prefilled insulin delivery device Rx only 5 x 3 mL Prefilled Pens Read Insulin Delivery Device Instructions for Use PACKAGE CARTON – HUMALOG Tempo Pen
PACKAGE CARTON – STERILE DILUENT Vial 10mL 1ct 1–ND 800 Lilly 10 mL STERILE DILUENT FOR HUMALOG ® U-100 insulin lispro injection HUMULIN ® R U-100 REGULAR insulin human injection Insulin Lispro Injection U-100 WARNING: Use ONLY with insulins listed on side panel. PACKAGE CARTON – Sterile Diluent Vial 10 mL 1ct
PACKAGE CARTON – HUMALOG U200 KwikPen 2ct Dispense in this sealed carton. NDC 0002-7712-27 Humalog KwikPen® (insulin lispro) injection For Single Patient Use Only 200 units per mL (U-200) 2 x 3 mL Prefilled Pens For subcutaneous use only. prefilled insulin delivery device Rx only Read Insulin Delivery Device Instructions for Use. NEEDLES NOT INCLUDED This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT Exclamation PACKAGE CARTON - HUMALOG U200 KwikPen 2ct
PACKAGE CARTON – HUMALOG U-200 Tempo Pen Dispense in this sealed carton. NDC 0002-8208-27 Humalog ® Tempo Pen TM insulin lispro injection For Single Patient Use Only 200 units per mL (U-200) prefilled insulin delivery device 2 x 3 mL Prefilled Pens Rx Only For subcutaneous use. Read Insulin Delivery Device Instructions for Use. NEEDLES NOT INCLUDED This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT Exclamation PACKAGE CARTON – HUMALOG U-200 Tempo Pen

source: label

Packages (0)

No package records.

Ingredients (1)

insulin lispro (200 [iU]/mL)

Linked Drug Pages (1)

Humalog Junior KwikPen, Humalog, Humalog Tempo Pen, Humalog KwikPen, Sterile Diluent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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