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Sterile Diluent 1 mL/mL Injection, Solution, 10 mL — NDC 00002-0800-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sterile Diluent 1 mL/mL Injection, Solution, 10 mL — NDC 0002-0800-00 (Billing 00002-0800-00)

by Eli Lilly and Company · 10 mL in 1 VIAL, MULTI-DOSE

This is a package of 10 mL of Sterile Diluent 1 mL/mL Injection, Solution from Eli Lilly and Company, marketed since Jul 1987 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00002-0800-00
🏷️ FDA NDC (as labeled) 0002-0800-00 billing pads the labeler segment with a zero
This package
Contains10 mL Pack sizes2 compare ↓
Main listing for product 0002-0800 · Also comes in: 10 mL 0002-0800-01
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0002-0800-00 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0002 labeler · 0800 product · 00 package
Package marketed since
Jul 10, 1987
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0002080000 1
FDA record last changed
Oct 1, 2026
Past resolved recalls for this product (2)
Class II · Mar 12, 2024 · Completed — CGMP Deviations (Eli Lilly & Company) · FDA recall D-0445-2024
Class I · Apr 5, 2022 · Completed — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. (Cardinal Health Inc.) · FDA recall D-0882-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0002-0800-00
Product NDC 0002-0800
11-digit billing NDC 00002080000
RxCUI 242120, 865098, 1652239, 1652242, 1652639, 1652640, 1652644, 1652646,
UNII 059QF0KO0R, GFX7QIS1II
Application # BLA020563
SPL Set ID c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f
Established class (EPC) Insulin Analog
Chemical class Insulin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-07-10
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance WATER

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 084391
GCN 53687
HICL code 048679
Ingredient (HICL) Diluent,Insulin Lispro,Regular
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5O
Therapeutic class — specific (HIC3) Diluent Solutions
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name STERILE DILUENT FOR HUMALOG VL
FDB brand name Sterile Diluent For Humalog
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084391
  • GCN: 53687
  • HICL (First Databank): 048679
  • AHFS class code: 96:00.00.00
  • RxCUI (RxNorm): 242120
Why two NDCs? The FDA registers this code as 0002-0800-00 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00002-0800-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Insulin Analog class.

Pharmacologic class Insulin Analog
Drug family (ATC) Insulins and analogues for injection, fast-acting, Insulins and analogues for injection, intermediate-acting, Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name STERILE DILUENT FOR HUMALOG VL Ingredient Diluent,Insulin Lispro,Regular
📗 Our plain-language guide HelloPharmacist
  • It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
  • Why is 'water' listed as the active ingredient on my medicine?
  • No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
  • Is Sterile Water for Injection the same as the eye wash or the irrigation product?
📖 Read our full Water guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00002-0800-01 0002-0800-01 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 1987-07-10 — Active
00002-0800-00 You're viewing this Main listing 10 mL in 1 VIAL, MULTI-DOSE — — Active

Pack size FAQ

What quantity is in this package?
This package contains 10 mL — 10 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Sterile Diluent 1 mL/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sterile Diluent 1 mL/mLthis 00002-0800-00 Eli 10 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
1987
On the market since
Jul 1987
📍
2026
Currently FDA-listed
39 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 16 mg / 1 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 1.6 mg / 1 mL UNII GGO4Y809LO
    Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
  • 0.65 mg / 1 mL UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 3.8 mg / 1 mL UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEli Lilly and Company
FDA applicationBLA020563 (BLA)
Labeler code00002
First marketedJul 1987
Product typeHuman Prescription Drug
Portfolio192 products on file

More NDCs from Eli Lilly and Company labeler code 00002

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 , 2.3 , 2.4 ) Subcutaneous injection ( 2.2 ): Administer HUMALOG ® U-100 or U-200 by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if HUMALOG can be used. Use in accordance with the insulin pump instructions for use. Administer HUMALOG U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.

Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. DO NOT administer HUMALOG U-200 by continuous subcutaneous infusion. Intravenous Infusion ( 2.2 ): Administer HUMALOG U-100 by intravenous infusion ONLY after dilution and under medical supervision.

DO NOT administer HUMALOG U-200 by intravenous infusion. The dosage of HUMALOG must be individualized based on the route of administration and the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) Do not perform dose conversion when using the HUMALOG U-100 or U-200 prefilled pens.

The dose window shows the number of insulin units to be delivered and no conversion is needed. ( 2.1 , 2.3 ) Do not mix HUMALOG U-200 with any other insulin. ( 2.4 )

2.1Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . Inspect HUMALOG visually before use. It should appear clear and colorless.

Do not use HUMALOG if particulate matter or coloration is seen. Use HUMALOG prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose. Do NOT mix HUMALOG U-100 with other insulins when using a continuous subcutaneous infusion pump.

Do NOT transfer HUMALOG U-200 from the prefilled pen to a syringe for administration [see Warnings and Precautions ( 5.4 )] . Do NOT perform dose conversion when using any HUMALOG U-100 or U-200 prefilled pens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

2.2Administration Instructions for the Approved Routes of Administration Subcutaneous Injection: HUMALOG U-100 or U-200 Administer the dose of HUMALOG U-100 or HUMALOG U-200 within fifteen minutes before a meal or immediately after a meal by injection into the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.

Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6 )] . During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] . HUMALOG administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.

The HUMALOG U-100 KwikPen, HUMALOG U-100 Tempo Pen, and HUMALOG U-200 KwikPen each dial in 1 unit increments and delivers a maximum dose of 60 units per injection. The HUMALOG U-100 Junior KwikPen dials in 0.5 unit increments and delivers a maximum dose of 30 units per injection. Subcutaneous Injection: Diluted HUMALOG U-100 HUMALOG U-100 may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection ONLY under medical supervision.

Dilute one part HUMALOG U-100 to: Nine parts diluent to yield a concentration one-tenth that of HUMALOG U-100 (equivalent to U-10). One part diluent to yield a concentration one-half that of HUMALOG U-100 (equivalent to U-50). D… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 124 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) clear and colorless solution available as: 10 mL multiple-dose vial 3 mL multiple-dose vial 3 mL single-patient-use KwikPen prefilled pen 3 mL single-patient-use Tempo Pen prefilled pen 3 mL single-patient-use Junior KwikPen prefilled pen 3 mL single-patient-use cartridges Injection: 200 units/mL (U-200) clear and colorless solution available as: 3 mL single-patient-use KwikPen prefilled pen Injection: 100 units/mL (U-100) is available as: ( 3 ) 10 mL multiple-dose vial 3 mL multiple-dose vial 3 mL single-patient-use KwikPen ® prefilled pen 3 mL single-patient-use Tempo Pen™ prefilled pen 3 mL single-patient-use Junior KwikPen ® prefilled pen 3 mL single-patient-use cartridges Injection: 200 units/mL (U-200) is available as: ( 3 ) 3 mL single-patient-use KwikPen ® prefilled pen

⛔ Contraindications 71 words ▾

4 CONTRAINDICATIONS HUMALOG is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . in patients who are hypersensitive to insulin lispro or to any of the excipients in HUMALOG [see Warnings and Precautions ( 5.5 )] . Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to insulin lispro or any of the excipients in HUMALOG. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share a HUMALOG prefilled pen, cartridge, reusable pen compatible with Lilly 3 mL cartridges, or syringe between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening.

Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. ( 5.3 , 7 , 8.6 , 8.7 ) Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.

Do not transfer HUMALOG U-200 from the HUMALOG prefilled pen to a syringe as overdosage and severe hypoglycemia can result. ( 5.4 ) Hypersensitivity Reactions: May be life-threatening. Discontinue HUMALOG, monitor and treat if indicated.

( 5.5 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. ( 5.6 ) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.

( 5.7 ) Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer HUMALOG U-100 by subcutaneous injection if pump malfunction occurs. ( 5.8 )

5.1Never Share a HUMALOG Prefilled Pen, Cartridge, Reusable Pen Compatible with Lilly 3 mL Cartridges 1 , or Syringe Between Patients 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. Sharing poses a risk for transmission of blood-borne pathogens.

5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3 )] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions ( 6 )] .

Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including HUMALOG. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly, and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions ( 7 )] , or in patients who experie… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )]. Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )].

Hypokalemia [see Warnings and Precautions ( 5.6 )] . Adverse reactions associated with HUMALOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% of patients treated with insulin lispro or regular human insulin. The frequencies of adverse reactions during HUMALOG clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Adverse Reactions That Occurred in ≥5% in Patients with Type 1 Diabetes Mellitus HUMALOG (%) (n=81) Regular human insulin (%) (n=86) Flu syndrome 34.6

32.6Pharyngitis 33.3

33.7Rhinitis 24.7

29.1Headache 29.6

22.1Pain 19.8

16.3Cough increased 17.3

17.4Infection 13.6

20.9Nausea 6.2

15.1Accidental injury 8.6

11.6Surgical procedure 6.2

14.0Fever 6.2

11.6Abdominal pain 7.4

8.1Asthenia 7.4

8.1Bronchitis 7.4

7.0Diarrhea 8.6

5.8Dysmenorrhea 6.2

7.0Myalgia 7.4

5.8Urinary tract infection 6.2

4.7Table 2: Adverse Reactions That Occurred in ≥5% in Patients with Type 2 Diabetes Mellitus HUMALOG (%) (n=714) Regular human insulin (%) (n=709) Headache 11.6

9.3Pain 10.8

10.0Infection 10.1

7.6Pharyngitis 6.6

8.2Rhinitis 8.1

6.6Flu syndrome 6.2

8.2Surgical procedure 7.4

6.8Insulin initiation and intensification of glucose control Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMALOG.

Lipodystrophy Long-term use of insulin, including HUMALOG, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption [see Dosage and Administration ( 2.2 )] . Weight gain Weight gain can occur with insulins, including HUMALOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Peripheral Edema Insulins, including HUMALOG, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII) — HUMALOG U-100 In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for HUMALOG U-100 and regular human insulin treated patients ( see Table 3 ). Table 3: Catheter Occlusions and Infusion Site Reactions HUMALOG U-100 (n=38) Regular human insulin (n=39) Catheter occlusions/month 0.09

0.10Infusion site reactions 2.6% (1/38) 2.6% (1/39) In a randomized, 16-week, open-label, parallel design study of pediatric patients with type 1 diabetes, adverse reactions related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patie… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS The table below includes clinically significant drug interactions with HUMALOG. Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Decrease the Blood Glucose Lowering Effect of HUMALOG Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of HUMALOG Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine and reserpine. Intervention: Increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs. Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics ( 7 ).

Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones ( 7 ). Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine ( 7 ). Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine ( 7 ).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis.

No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see Data) . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10.

The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. However, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups.

Animal Data In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19. There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter.

In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation days 7 through 19. There were no adverse effects on fetal viability, weight, and morphology at any dose.

8.2Lactation Risk Summary Available data from published literature suggests that exogenous human insulin products, including insulin lispro, are transferred into human milk. There are no adverse reactions reported in breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including insulin lispro, on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from HUMALOG or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of HUMALOG to improve glycemic control have been established in pediatric pat… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis.

No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see Data) . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10.

The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. However, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups.

Animal Data In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19. There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter.

In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation days 7 through 19. There were no adverse effects on fetal viability, weight, and morphology at any dose.

🧒 Pediatric Use 76 words ▾

8.4Pediatric Use The safety and effectiveness of HUMALOG to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of HUMALOG for this indication is supported by evidence from adequate and well-controlled studies in 831 pediatric patients with type 1 diabetes mellitus aged 3 years and older and from studies in adults with diabetes mellitus [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )].

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use Of the total number of patients (n=2,834) in eight clinical studies of HUMALOG, twelve percent (n=338) were 65 years of age or over. The majority of these patients had type 2 diabetes. HbA 1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of HUMALOG action have not been performed.

🆘 Overdosage 76 words ▾

10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

12.2Pharmacodynamics HUMALOG has been shown to be equipotent to human insulin on a molar basis. One unit of HUMALOG has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that HUMALOG has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously.

The time course of action of insulin and insulin analogs, such as HUMALOG, may vary considerably in different individuals or within the same individual. The parameters of HUMALOG activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption, and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables [see Warnings and Precautions ( 5.2 )] .

Figure 1: Blood Glucose Levels After Subcutaneous Injection of Regular Human Insulin or HUMALOG (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. Figure Intravenous Administration of HUMALOG U-100 — The glucose lowering effect of intravenously administered HUMALOG was tested in 21 patients with type 1 diabetes. For the study, the patients' usual doses of insulin were held and blood glucose concentrations were allowed to reach a stable range of 200 to 260 mg/dL during a one to three hours run-in phase.

The run-in phase was followed by a 6-hour assessment phase. During the assessment phase, patients received intravenous HUMALOG at an initial infusion rate of 0.5 units/hour. The infusion rate of HUMALOG could be adjusted at regular timed intervals to achieve and maintain blood glucose concentrations between 100 to 160 mg/dL.

The mean blood glucose levels during the assessment phase for patients on HUMALOG therapy are summarized below in Table 4 . All patients achieved the targeted glucose range at some point during the 6-hour assessment phase. At the endpoint, blood glucose was within the target range (100 to 160 mg/dL) for 17 of 20 patients treated with HUMALOG.

The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for HUMALOG. Table 4: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of HUMALOG U-100 a Results shown as mean ± SD Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous a 0 224 ± 16 30 205 ± 21 60 195 ± 20 120 165 ± 26 180 140 ± 26 240 123 ± 20 300 120 ± 27 360 122 ± 25 The pharmacodynamics of a single 20 unit dose of HUMALOG U-200 administered subcutaneously were compared to the pharmacodynamics of a single 20 unit dose of HUMALOG U-100 administered subcutaneously in a euglycemic clamp study enrolling healthy subjects.

In this study, the overall, maximum, and time to maximum glucose lowering effect were similar between HUMALOG U-200 and HUMALOG U-100. The mean area under the glucose infusion rate curves (measure of overall pharmacodynamic effect) were 125 g and 126 g for HUMALOG U-200 and HUMALOG U-100, respectively. The maximum glucose infusion rate was 534 mg/min and 559 mg/min and the corresponding median time (min, max) to maximum effect were 2.8 h (0.5 h – 6.3 h) and 2.4 h (0.5 h – 4.7 h) for HUMALOG U-200 and HUMALOG U-100, respectively.

12.3Pharmacokinetics Absorption and Bioavailability — Studies in healthy volunteers and patients with diabetes demonstrated that HUMALOG is absorbed more quickly than regular human insulin. In healthy volunteers… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How 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 The U-100 KwikPen, U-100 Tempo Pen, and U-200 KwikPen 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.

16.2Storage 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) 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 )] .

16.1How 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… [Excerpted — this section continues on DailyMed.]

📦 Storage and Handling ~2 min read ▾

16.2Storage 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) 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 )] .

📋 Description ~1 min read ▾

11 DESCRIPTION Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli . Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C 257 H 383 N 65 O 77 S 6 and a molecular weight of 5.808 kDa, both identical to that of human insulin.

Insulin lispro has the following primary structure: HUMALOG (insulin lispro) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL of HUMALOG U-100 contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.0 mg), glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Each mL of HUMALOG U-200 contains 200 units of insulin lispro, and the inactive ingredients: glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, tromethamine (5 mg), zinc oxide (content adjusted to provide 0.046 mg zinc ion), and Water for Injection, USP.

HUMALOG has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% is added to adjust the pH. Primary Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a HUMALOG Prefilled Pen, Cartridge, Reusable Pen Compatible with Lilly 3 mL Cartridges, or Syringe Between Patients Advise patients that they must never share a HUMALOG prefilled pen, cartridge, or reusable pen compatible with Lilly 3 mL cartridges with another person, even if the needle is changed. Advise patients using HUMALOG vials not to share needles or syringes with another person.

Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.1 )] . Hyperglycemia or Hypoglycemia Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of HUMALOG therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

Instruct patients on the management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions ( 5.3 )] .

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.2 )] . Hypoglycemia due to Medication Errors Instruct patients to always check the insulin container label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] . Inform patients that HUMALOG U-200 contains 2 times as much insulin per mL as HUMALOG U-100.

The HUMALOG U-200 prefilled pen dose window shows the number of units of HUMALOG U-200 to be injected so no dose conversion is required [see Dosage and Administration ( 2.1 )]. Instruct patients to NOT transfer HUMALOG U-200 from the HUMALOG U-200 prefilled pen to a syringe. The markings on the syringe will not measure the dose correctly and this can result in overdosage and severe hypoglycemia. [see Warnings and Precautions ( 5.4 )].

Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with HUMALOG. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] . Administration Instruction for HUMALOG U-200 Instruct patients to NOT mix HUMALOG U-200 with any other insulin.

Instructions For Patients Using Continuous Subcutaneous Insulin Pumps Do not use HUMALOG U-200 in a subcutaneous insulin pump. Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories. Instruct patients to follow healthcare provider recommendations when setting pump basal rates and bolus settings.

Refer to the continuous subcutaneous infusion pump user manual to see if HUMALOG can be used with the pump. See recommended reservoir and infusion sets in the insulin pump user manual. Instruct patients to replace insulin in the reservoir at least every 7 days, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers' user manual.

By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative. Instruct patients to discard insulin exposed to temperatures higher than 98.6°F (37°C). The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing or sport case is exposed to sunlight or radiant heat.

Instruct patients to inform healthcare provider and sele… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption and Bioavailability — Studies in healthy volunteers and patients with diabetes demonstrated that HUMALOG is absorbed more quickly than regular human insulin. In healthy volunteers given subcutaneous doses of HUMALOG ranging from 0.1 to 0.4 unit/kg, peak serum levels were seen 30 to 90 minutes after dosing. When healthy volunteers received equivalent doses of regular human insulin, peak insulin levels occurred between 50 to 120 minutes after dosing.

Similar results were seen in patients with type 1 diabetes ( see Figure 2 ). Figure 2: Serum HUMALOG and Insulin Levels After Subcutaneous Injection of Regular Human Insulin or HUMALOG (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. HUMALOG U-100 was absorbed at a consistently faster rate than regular human insulin in healthy male volunteers given 0.2 unit/kg at abdominal, deltoid, or femoral subcutaneous sites.

After HUMALOG was administered in the abdomen, serum drug levels were higher and the duration of action was slightly shorter than after deltoid or thigh administration. Bioavailability of HUMALOG is similar to that of regular human insulin. The absolute bioavailability after subcutaneous injection ranges from 55% to 77% with doses between 0.1 to 0.2 unit/kg, inclusive.

The results of a study in healthy subjects demonstrated that HUMALOG U-200 is bioequivalent to HUMALOG U-100 following administration of a single 20 unit dose. The mean observed area under the serum insulin concentration-time curve from time zero to infinity was 2360 pmol hr/L and 2390 pmol hr/L for HUMALOG U-200 and HUMALOG U-100, respectively. The corresponding mean peak serum insulin concentration was 795 pmol/L and 909 pmol/L for HUMALOG U-200 and HUMALOG U-100, respectively.

The median time to maximum concentration was 1.0 hour for both formulations. Figure Distribution — When administered intravenously as bolus injections of 0.1 and

0.2U/kg dose in two separate groups of healthy subjects, the mean volume of distribution of HUMALOG appeared to decrease with increase in dose (1.55 and

0.72L/kg, respectively) in contrast to that of regular human insulin for which, the volume of distribution was comparable across the two dose groups (1.37 and

1.12L/kg for 0.1 and

0.2U/kg dose, respectively). Metabolism — Human metabolism studies have not been conducted. However, animal studies indicate that the metabolism of HUMALOG is identical to that of regular human insulin.

Elimination — After subcutaneous administration of HUMALOG, the t 1/2 is shorter than that of regular human insulin (1 versus 1.5 hours, respectively). When administered intravenously, HUMALOG and regular human insulin demonstrated similar dose-dependent clearance, with a mean clearance of 21.0 mL/min/kg and 21.4 mL/min/kg, respectively (0.1 unit/kg dose), and 9.6 mL/min/kg and 9.4 mL/min/kg, respectively (0.2 unit/kg dose). Accordingly, HUMALOG demonstrated a mean t 1/2 of 0.85 hours (51 minutes) and 0.92 hours (55 minutes), respectively for 0.1 unit/kg and 0.2 unit/kg doses, and regular human insulin mean t 1/2 was 0.79 hours (47 minutes) and 1.28 hours (77 minutes), respectively for 0.1 unit/kg and 0.2 unit/kg doses.

Specific Populations The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMALOG have not been studied. Renal Impairment — Type 2 diabetic patients with varying degree of renal impairment showed no difference in pharmacokinetics of regular insulin and HUMALOG. However, the sensitivity of the patients to insulin did change, with an increased response to insulin as the renal function declined.

Some studies with human insulin have shown increased circulating levels of insulin in patients with renal impairment [see Use in Specific Populations ( 8.6 )]. Hepatic Impairment — Type 2 diabetic patients with impaired hepatic func… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics HUMALOG has been shown to be equipotent to human insulin on a molar basis. One unit of HUMALOG has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that HUMALOG has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously.

The time course of action of insulin and insulin analogs, such as HUMALOG, may vary considerably in different individuals or within the same individual. The parameters of HUMALOG activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption, and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables [see Warnings and Precautions ( 5.2 )] .

Figure 1: Blood Glucose Levels After Subcutaneous Injection of Regular Human Insulin or HUMALOG (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. Figure Intravenous Administration of HUMALOG U-100 — The glucose lowering effect of intravenously administered HUMALOG was tested in 21 patients with type 1 diabetes. For the study, the patients' usual doses of insulin were held and blood glucose concentrations were allowed to reach a stable range of 200 to 260 mg/dL during a one to three hours run-in phase.

The run-in phase was followed by a 6-hour assessment phase. During the assessment phase, patients received intravenous HUMALOG at an initial infusion rate of 0.5 units/hour. The infusion rate of HUMALOG could be adjusted at regular timed intervals to achieve and maintain blood glucose concentrations between 100 to 160 mg/dL.

The mean blood glucose levels during the assessment phase for patients on HUMALOG therapy are summarized below in Table 4 . All patients achieved the targeted glucose range at some point during the 6-hour assessment phase. At the endpoint, blood glucose was within the target range (100 to 160 mg/dL) for 17 of 20 patients treated with HUMALOG.

The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for HUMALOG. Table 4: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of HUMALOG U-100 a Results shown as mean ± SD Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous a 0 224 ± 16 30 205 ± 21 60 195 ± 20 120 165 ± 26 180 140 ± 26 240 123 ± 20 300 120 ± 27 360 122 ± 25 The pharmacodynamics of a single 20 unit dose of HUMALOG U-200 administered subcutaneously were compared to the pharmacodynamics of a single 20 unit dose of HUMALOG U-100 administered subcutaneously in a euglycemic clamp study enrolling healthy subjects.

In this study, the overall, maximum, and time to maximum glucose lowering effect were similar between HUMALOG U-200 and HUMALOG U-100. The mean area under the glucose infusion rate curves (measure of overall pharmacodynamic effect) were 125 g and 126 g for HUMALOG U-200 and HUMALOG U-100, respectively. The maximum glucose infusion rate was 534 mg/min and 559 mg/min and the corresponding median time (min, max) to maximum effect were 2.8 h (0.5 h – 6.3 h) and 2.4 h (0.5 h – 4.7 h) for HUMALOG U-200 and HUMALOG U-100, respectively.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of HUMALOG U-100 were studied in pediatric and adult patients with type 1 diabetes (n=789) and adult patients with type 2 diabetes (n=722).

14.1Type 1 Diabetes – Adults and Pediatric Patients Aged 12 Years and Older A 12-month, randomized, parallel, open-label, active-controlled study was conducted in patients with type 1 diabetes to assess the safety and efficacy of HUMALOG (n=81) compared with Humulin ® R [insulin human injection (100 units/mL)] (n=86). HUMALOG was administered by subcutaneous injection immediately prior to meals and Humulin R was administered 30 to 45 minutes before meals. Humulin ® U [ULTRALENTE ® human insulin (rDNA origin) extended zinc suspension] was administered once or twice daily as the basal insulin.

There was a 2- to 4-week run-in period with Humulin R and Humulin U before randomization. Most patients were Caucasian (97%). Forty-seven percent of the patients were male.

The mean age was 31 years (range 12 to 70 years). Glycemic control, the total daily doses of HUMALOG and Humulin R, and the incidence of severe hypoglycemia (as determined by the number of events that were not self-treated) were similar in the two treatment groups. There were no episodes of diabetic ketoacidosis in either treatment group.

Table 5: Type 1 Diabetes Mellitus – Adults and Pediatric Patients Aged 12 years and Older a Values are Mean ± SD b Severe hypoglycemia refers to hypoglycemia for which patients were not able to self-treat. Treatment Duration Treatment in Combination with: 12 months Humulin U HUMALOG Humulin R N 81 86 Baseline HbA 1c (%) a 8.2 ± 1.4 8.3 ±

1.7Change from baseline HbA 1c (%) a -0.1 ± 0.9 0.1 ±

1.1Treatment Difference in HbA 1c Mean (95% confidence interval) 0.4 (0.0, 0.8) Baseline short-acting insulin dose (units/kg/day) 0.3 ± 0.1 0.3 ±

0.1End-of-Study short-acting insulin dose (units/kg/day) 0.3 ± 0.1 0.3 ±

0.1Change from baseline short-acting insulin dose (units/kg/day) 0.0 ± 0.1 0.0 ±

0.1Baseline Body weight (kg) 72 ± 12.7 71 ±

11.3Weight change from baseline (kg) 1.4 ± 3.6 1.0 ±

2.6 Patients with severe hypoglycemia (n, %) b 14 (17%) 18 (21%)

14.2Type 1 Diabetes – Pediatric Patients An 8-month, crossover study of pediatric patients with type 1 diabetes (n=463), aged 9 to 19 years, compared two subcutaneous multiple-dose treatment regimens: HUMALOG or Humulin R, both administered with Humulin N (NPH human insulin) as the basal insulin. HUMALOG achieved glycemic control comparable to Humulin R, as measured by HbA 1c ( see Table 6 ), and both treatment groups had a comparable incidence of hypoglycemia. In a 9-month, crossover study of pediatric patients (n=60) with type 1 diabetes, aged 3 to 11 years, HUMALOG administered immediately before meals, HUMALOG administered immediately after meals and Humulin R administered 30 minutes before meals resulted in similar glycemic control, as measured by HbA 1c , and incidence of hypoglycemia, regardless of treatment group.

Table 6: Pediatric Subcutaneous Administration of HUMALOG in Type 1 Diabetes a Values are Mean ± SD b Severe hypoglycemia refers to hypoglycemia that required glucagon or glucose injection or resulted in coma. End point Baseline HUMALOG + NPH Humulin R + NPH HbA 1c (%) a 8.6 ± 1.5 8.7 ± 1.5 8.7 ±

1.6Change from baseline HbA 1c (%) a — 0.1 ± 1.1 0.1 ±

1.3Short-acting insulin dose (units/kg/day) a 0.5 ± 0.2 0.5 ± 0.2 0.5 ±

0.2Change from baseline short-acting insulin dose (units/kg/day) a — 0.01 ± 0.1 -0.01 ±

0.1Body weight (kg) a 59.1 ± 13.1 61.1 ± 12.7 61.4 ±

12.9Weight change from baseline (kg) a — 2.0 ± 3.1 2.3 ±

3.0Patients with severe hypoglycemia (n, %) b — 5 (1.1%) 5 (1.1%) Diabetic ketoacidosis (n, %) — 11 (2.4%) 9 (1.9%)

14.3Type 1 Diabetes – Adults Continuous Subcutaneous Insulin Infusion To evaluate the administration of HUMALOG U-100 via external insulin pumps, two open-label, crossover design studies were performed in patients with type 1 diabetes. One study involved 39 p… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose.

Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration and micronucleus assays. Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

13.2Animal Toxicology and/or Pharmacology In standard biological assays in fasted rabbits, 0.2 unit/kg of insulin lispro injected subcutaneously had the same glucose-lowering effect and had a more rapid onset of action as 0.2 unit/kg of regular human insulin.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 186 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose.

Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration and micronucleus assays. Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert This Patient Information has been approved by the U.S. Food and Drug Administration Revised: May 2025 PATIENT INFORMATION HUMALOG ® (HU-ma-log) (insulin lispro) injection, for subcutaneous use Do not share your HUMALOG prefilled pens, cartridges, reusable pen compatible with 3 mL cartridges of HUMALOG U-100, needles, or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

What is HUMALOG? HUMALOG is a rapid-acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus. Who should not take HUMALOG?

Do not take HUMALOG if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin lispro or any of the ingredients in HUMALOG. See the end of this Patient Information leaflet for a complete list of ingredients in HUMALOG. What should I tell my healthcare provider before taking HUMALOG?

Before taking HUMALOG, tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems. take any other medicines, especially ones called TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with HUMALOG. are pregnant or plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. are breastfeeding or plan to breastfeed.

Talk with your healthcare provider about the best way to feed your baby while taking HUMALOG. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start taking HUMALOG, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use HUMALOG? Read the detailed Instructions for Use that comes with your HUMALOG. Take HUMALOG exactly as your healthcare provider tells you to.

Your healthcare provider should tell you how much HUMALOG to take and when to take it. Know the type, strength and amount of insulin you take. Do not change the type or amount of insulin you take unless your healthcare provider tells you to.

The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin. Check your insulin label each time you give your injection to make sure you are taking the correct insulin. Always use a new needle for each injection to help prevent infections and blocked needles.

Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them. HUMALOG is a rapid-acting insulin.

Inject HUMALOG within 15 minutes before or right after eating a meal. HUMALOG comes in U-100 (100 units/mL) and U-200 (200 units/mL) insulin strengths. HUMALOG U-200 contains 2 times as much insulin (200 units/mL) in 1 mL as HUMALOG U-100 (100 units/mL).

HUMALOG U-100 comes in a vial, single-patient-use prefilled pens, or in a cartridge. HUMALOG U-200 comes in single-patient-use prefilled pens. Do not use a syringe to remove HUMALOG U-100 or HUMALOG U-200 from your single-patient-use prefilled pen or HUMALOG U-100 cartridge.

The dose window on your HUMALOG U-100 or HUMALOG U-200 prefilled pen shows your dose of HUMALOG. Do not make any dose changes unless your healthcare provider tells you to. Inject HUMALOG U-100 or HUMALOG U-200 under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms HUMALOG U-100 can be given by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.

HUMALOG U-200 cannot be given through an insulin pump. HUMALOG U-100 can also be given in your vein (intravenously) by your healthcare provider. HUMALOG U-200 cannot be given in yo… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

U-100 Vial Instructions for Use INSTRUCTIONS FOR USE HUMALOG ® (HU-ma-log) (insulin lispro) injection, for subcutaneous use 3 mL or 10 mL multiple-dose vial (100 units per mL, U-100) Read this Instructions for Use before you start taking HUMALOG and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your needles or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. Supplies needed to give your injection a multiple-dose HUMALOG vial a U-100 insulin syringe and needle 2 alcohol swabs gauze 1 sharps container for throwing away used needles and syringes.

See “ Disposing of used needles and syringes ” at the end of these instructions. Vial Syringe Preparing your HUMALOG dose Wash your hands with soap and water. Check the HUMALOG label to make sure you are taking the right type of insulin.

This is especially important if you use more than 1 type of insulin. HUMALOG should look clear and colorless. Do not use HUMALOG if it is thick, cloudy, or colored, or if you see lumps or particles in it.

Do not use HUMALOG past the expiration date printed on the label or 28 days after you first use it. Always use a new syringe and needle for each injection to prevent infections and blocked needles. Do not reuse or share your syringes or needles with other people.

You may give other people a serious infection or get a serious infection from them. Step 1: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper. Step 2: Wipe the Rubber Stopper with an alcohol swab.

Step 3: Remove the Needle Shield from the syringe by pulling the Needle Shield straight off. Hold the syringe with the needle pointing up. Pull down on the Plunger until the Plunger Tip reaches the line for the number of units for your prescribed dose.

(Example Dose: 20 units shown) Step 4: Push the needle through the Rubber Stopper of the vial. Step 5: Push the Plunger all the way in. This puts air into the vial.

Step 6: Turn the vial and syringe upside down and slowly pull the Plunger down until the Plunger Tip is a few units past the line for your prescribed dose. (Example Dose: 20 units Plunger is shown at 24 units) If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top. Step 7: Slowly push the Plunger up until the Plunger Tip reaches the line for your prescribed dose.

Check the syringe to make sure that you have the right dose. (Example Dose: 20 units shown) Step 8: Pull the syringe out of the Rubber Stopper of the vial. If you use HUMALOG with NPH insulin: NPH insulin is the only type of insulin that can be mixed with HUMALOG.

Do not mix HUMALOG with any other type of insulin. HUMALOG should be drawn up into the syringe first, before you draw up your NPH insulin. Talk to your healthcare provider if you are not sure about the right way to mix HUMALOG and NPH insulin.

Give your injection right away. Giving your HUMALOG injection with a syringe Inject your insulin exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you should pinch the skin before injecting.

HUMALOG starts acting fast, so give your injection within 15 minutes before or right after you eat a meal. Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not inject where the skin has pits, is thickened, or has lumps.

Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Step 9: Choose your injection site. HUMALOG is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms.

Wipe… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2.2 ) 01/2026

📄 Package Label / Principal Display Panel ~2 min read ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00002-0800-01). Each has its own NDC and its own page — see the package list near the top of this page.
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Eli Lilly and Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
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← 00002-0770-04 · Eli 00002-0872-00 · Eli →
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