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Humalog Mix75/25 Insulin lispro 100 [iU]/mL Injection, Suspension — NDC 00002-7511-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humalog Mix75/25 Insulin lispro 100 [iU]/mL Injection, Suspension — NDC 0002-7511-99 (Billing 00002-7511-99)

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

This is a package of Humalog Mix75/25 Insulin lispro 100 [iU]/mL Injection, Suspension from Eli Lilly and Company, marketed since Dec 1999 and currently FDA-listed.

NDC 00002-7511-99
🏷️ FDA NDC (as labeled) 0002-7511-99 billing pads the labeler segment with a zero
This package
Contains10 mL in 1 vial, multi-dose Pack sizes2 compare ↓
Product page 00002-7511-01 Also comes in: 10 mL 0002-7511-01
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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 0002-7511-99 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0002 labeler · 7511 product · 99 package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0300027511016
FDA record last changed
Aug 20, 2026
⚠️
Other active recalls for Insulin Lispro (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 11, 2023 — Lack of Assurance of Sterility: Malformed crimped collar seal (Sanofi-Aventis U.S. LLC) · FDA recall D-0575-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0002-7511-99
Product NDC 0002-7511
11-digit billing NDC 00002751199
RxCUI 259111, 752388, 847252, 847254
UNII GFX7QIS1II
UPC 0300027511016
Application # BLA021017
SPL Set ID c73da51a-1899-45ad-b6cf-9c52c36a25dd
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 1999-12-22
Route SUBCUTANEOUS
Dosage form INJECTION, SUSPENSION
Substance INSULIN LISPRO
Biologic (Purple Book) 351(a)
Quick answers
  • RxCUI (RxNorm): 259111
Why two NDCs? The FDA registers this code as 0002-7511-99 — 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 → 00002-7511-99. 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.

Clinical

📖 What it is MedlinePlus · NLM

Insulin lispro injection products are used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Insulin lispro injection products are also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In patients with type 1 diabetes, insulin lispro injection products are always used with another type of insulin, unless it is used in an external insulin pump. In...

Read the full MedlinePlus article ↗
1
Nutrient depletion considerations

Insulin Lispro may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Insulin Lispro nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
Medicare Part B allowsASP · J1815 No ASP payment limit on file for J1815 this quarter.
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.

Billing & reimbursement

FDA NDC (as labeled)0002-7511-99
11-digit billing NDC00002-7511-99
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1815
DescriptorINJECTION, INSULIN, PER 5 UNITS
Billing units / pkg20 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 5 U, so one package = 20 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00002-7511-01 0002-7511-01 Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE $8.15 / mL $81.53 2000-10-10 — Active
00002-7511-99 You're viewing this 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE — — 2007-12-07 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Humalog Mix75/25 Insulin lispro 100 [iU]/mL Injection, Suspension?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Humalog Tempo Pen 100 [iU]/mL 00002-8213-05 Eli 5 syringes $10.127 — Availability likely —
Humalog Mix50/50 KwikPen 100 [iU]/mL 00002-8798-59 Eli 5 syringes $10.141 — Availability likely —
Humalog Junior KwikPen 100 [iU]/mL 00002-7714-59 Eli 5 syringes $10.158 — Availability likely —
Humalog Mix75/25 KwikPen 100 [iU]/mL 00002-8797-59 Eli 5 syringes $10.167 — Availability likely —
Insulin Lispro Junior KwikPen 100 [iU]/mL 00002-7752-05 Eli 5 syringes $10.199 — Availability likely —
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen 100 [iU]/mL 00002-8233-05 Eli 5 syringes $10.207 — Availability likely —
Humalog Mix75/25 100 [iU]/mLthis 00002-7511-99 Eli 1 vial — — 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

🏛️
1996
First FDA approval
Jun 1996
📍
2026
Currently FDA-listed
30 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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Admeloginsulin lispro Humaloginsulin lispro Lyumjevinsulin lispro-aabc
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
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.
  • 1.76 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.
  • .715 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.
  • 0.28 mg / 1 mL UNII 0DE9724IHC
    Protamine sulfate is a protein derived from fish sperm that acts as a binder and stabilizer in medications. It helps hold tablet ingredients together and can improve the stability of certain drug formulations.
  • 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.
  • 3.78 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • .025 mg / 1 mL UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

9 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 applicationBLA021017 (BLA)
Labeler code00002
First marketedDec 1999
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 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 104 words ▾

1 INDICATIONS AND USAGE HUMALOG Mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. HUMALOG ® Mix75/25™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. ( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.

( 1 ) Limitations of Use : The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important preparation and administration instructions. ( 2.1 ) Inject HUMALOG Mix75/25 subcutaneously (within 15 minutes before a meal) in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 , 2.2 ) Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal.

( 2.2 ) Do not administer HUMALOG Mix75/25 intravenously or by a continuous subcutaneous insulin infusion pump. ( 2.1 ) HUMALOG Mix75/25 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). ( 2.2 )

2.1Important Preparation and Administration Instructions Preparation Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . HUMALOG Mix75/25 is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature.

To resuspend the: vial, carefully invert the vial at least 10 times until the suspension appears uniformly white and cloudy. KwikPen, gently roll the KwikPen at least 10 times and then carefully invert the KwikPen at least 10 times until the suspension appears uniformly white and cloudy. Inspect HUMALOG Mix75/25 visually before use.

Do not use if discoloration or particulate matter is seen. Administration Instructions After resuspension, immediately administer HUMALOG Mix75/25 by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks. Rotate the injection site within the same region from one injection to the next 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 )] . The HUMALOG Mix75/25 KwikPen dials in 1 unit increments. Use HUMALOG Mix75/25 KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose.

Do not administer HUMALOG Mix75/25 intravenously or by a continuous subcutaneous insulin infusion pump. Do not mix HUMALOG Mix75/25 with any other insulins or diluents.

2.2Dosage Recommendations Individualize and adjust the dosage of HUMALOG Mix75/25 based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Inject HUMALOG Mix75/25 subcutaneously within 15 minutes before a meal. HUMALOG Mix75/25 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack).

Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )] . When switching from another insulin to HUMALOG Mix75/25 a different dosage of HUMALOG Mix75/25 may be needed. During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] .

2.3Dosage Modifications for Drug Interactions Dosage modification may be needed when HUMALOG Mix75/25 is used concomitantly with certain drugs [see Drug Interactions ( 7 )] .

💊 Dosage Forms and Strengths 71 words ▾

3 DOSAGE FORMS AND STRENGTHS Injectable suspension: 100 units/mL (U-100) of HUMALOG Mix75/25, 75% insulin lispro protamine and 25% insulin lispro, is a white and cloudy suspension available as: 10 mL multiple-dose vial 3 mL single-patient-use KwikPen prefilled pen Injectable suspension: 100 units/mL (U-100) of HUMALOG Mix75/25, 75% insulin lispro protamine and 25% insulin lispro available as: ( 3 ) 10 mL multiple-dose vial 3 mL single-patient-use KwikPen ® prefilled pen

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS HUMALOG Mix75/25 is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] in patients who have had hypersensitivity reactions to HUMALOG Mix75/25 or to any of its excipients. [see Warnings and Precautions ( 5.5 )] Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to HUMALOG Mix75/25 or any of its excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share a HUMALOG Mix75/25 KwikPen 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.

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

( 5.4 ) Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue HUMALOG Mix75/25, 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 reductions or discontinuation if heart failure occurs. ( 5.7 )

5.1Never Share a HUMALOG Mix75/25 KwikPen or Syringe Between Patients HUMALOG Mix75/25 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMALOG Mix75/25 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 anti-diabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with all insulins, including HUMALOG Mix75/25. Severe hypoglycemia can cause seizures, may lead to unconsciousness, 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 experience recurrent hypoglycemia. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and in general, is highest when the glucose lowering effect of the insulin is maximal.

As with all insulins, the glucose lowering effect time course of HUMALOG Mix75/25 may vary in different individuals or at different times in the same… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: 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 observed with HUMALOG Mix75/25 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, edema, pruritus, and rash. ( 6 ) 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.

Adverse Reactions from Clinical Studies or Postmarketing Reports The following adverse reactions have been identified during post-marketing use of HUMALOG Mix75/25. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions associated with insulin initiation and glucose control intensification 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.

Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypersensitivity reactions Severe, life-threatening, generalized allergy, including anaphylaxis. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in HUMALOG Mix75/25.

Hypokalemia HUMALOG Mix75/25 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Injection site reactions HUMALOG Mix75/25 can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation.

Localized reactions and generalized myalgias have been reported with the use of meta-cresol, which is an excipient in HUMALOG Mix75/25. Lipodystrophy Administration of insulin subcutaneously, including HUMALOG Mix75/25, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.1 )] in some patients. Localized cutaneous amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.

Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site. Medication Errors Medication errors in which other insulins have been accidentally substituted for HUMALOG Mix75/25 have been identified during postapproval use. Peripheral Edema Insulins, including HUMALOG Mix75/25, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Weight gain Weight gain can occur with insulins, including HUMALOG Mix75/25, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria. Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The incidence of antibody formation with HUMALOG Mix75/25 is unknown.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 1 below presents clinically significant drug interactions with HUMALOG Mix75/25. Table 1: Clinically Significant Drug Interactions with HUMALOG Mix75/25 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 analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG Mix75/25 is co-administered with these drugs.

Drugs that May Decrease the Blood Glucose Lowering Effect of HUMALOG Mix75/25 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 Mix75/25 is co-administered with these drugs.

Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of HUMALOG Mix75/25 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 Mix75/25 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 Mix75/25 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, still birth, 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 Animal reproduction studies have not been performed with HUMALOG Mix75/25. However, subcutaneous reproduction and teratology studies have been conducted with insulin lispro (a component of HUMALOG Mix75/25). 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 HUMALOG Mix75/25, 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 HUMALOG Mix75/25, 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 e… [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, still birth, 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 Animal reproduction studies have not been performed with HUMALOG Mix75/25. However, subcutaneous reproduction and teratology studies have been conducted with insulin lispro (a component of HUMALOG Mix75/25). 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 16 words ▾

8.4Pediatric Use Safety and effectiveness of HUMALOG Mix75/25 in pediatric patients have not been established.

🧓 Geriatric Use 60 words ▾

8.5Geriatric Use Clinical studies of Humalog Mix75/25 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In patients aged 65 and over with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.3 )].

🆘 Overdosage 85 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 [see Warnings and Precautions ( 5.3 , 5.6 )].

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary activity of insulin, including HUMALOG Mix75/25, is the regulation of glucose metabolism. 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 In a glucose clamp study performed in 30 healthy subjects, the onset of action and glucose-lowering activity of HUMALOG, HUMALOG ® Mix50/50™, HUMALOG Mix75/25, and insulin lispro protamine suspension (ILPS) were compared ( see Figure 1 ). Graphs of mean glucose infusion rate versus time showed a distinct insulin activity profile for each formulation. The rapid onset of glucose-lowering activity characteristic of HUMALOG was maintained in HUMALOG Mix75/25.

The median maximum pharmacologic effect of HUMALOG Mix75/25 after administration of a 0.3 unit/kg dose to healthy subjects occurred at approximately 2 hours (range: 1-6 hours); glucose lowering activity was detectable for a median of 22 hours (range: 13 to 22 hours), which was the end of the clamp. In separate glucose clamp studies performed in healthy subjects, pharmacodynamics of HUMALOG Mix75/25 and HUMULIN ® 70/30 were assessed and are presented in Figure 2 . HUMALOG Mix75/25 has a duration of activity similar to that of HUMULIN 70/30.

Figures 1 and 2 should be considered only as representative examples since the time course of action of insulin and insulin analogs, may vary in different individuals or within the same individual. Figure 1: Mean Insulin Activity Versus Time Profiles After Injection of 0.3 units/kg of HUMALOG, HUMALOG Mix50/50, HUMALOG Mix75/25, or Insulin Lispro Protamine Suspension (ILPS) in 30 Healthy Subjects. Figure 2: Mean Insulin Activity Versus Time Profiles After Injection of 0.3 units/kg of HUMALOG Mix75/25 or HUMULIN 70/30 in Healthy Subjects.

Figure 1 Figure 2

12.3Pharmacokinetics Absorption — HUMALOG Mix75/25 has two phases of absorption. The early phase represents insulin lispro and its distinct characteristics of rapid onset. The late phase represents the prolonged absorption of insulin lispro protamine suspension.

In 31 healthy subjects given subcutaneous doses (0.3 unit/kg) of HUMALOG Mix75/25, the median peak serum concentration was 60 minutes (range: 30 minutes to 4 hours) after dosing. Identical results were found in patients with type 1 diabetes. The rapid absorption characteristics of HUMALOG are maintained with HUMALOG Mix75/25.

HUMALOG Mix75/25 has a more rapid absorption than HUMULIN 70/30, which has been confirmed in patients with type 1 diabetes. Metabolism — Human metabolism studies of HUMALOG Mix75/25 have not been conducted. However, studies in animals indicate that the metabolism of HUMALOG, the rapid-acting component of HUMALOG Mix75/25, is identical to that of regular human insulin.

Elimination — Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve. Specific Populations The effects of age, race, obesity, pregnancy, smoking, or renal or hepatic impairment on the pharmacokinetics of HUMALOG Mix75/25 have not been studied. Gender — Pharmacokinetic and pharmacodynamic comparisons between men and women administered HUMALOG Mix75/25 showed no gender differences.

🧬 Mechanism of Action 47 words ▾

12.1Mechanism of Action The primary activity of insulin, including HUMALOG Mix75/25, is the regulation of glucose metabolism. 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 ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied HUMALOG Mix75/25 (insulin lispro protamine and insulin lispro) injectable suspension is a white and cloudy suspension of 100 units/mL (U-100) of 75% insulin lispro protamine and 25% insulin lispro available as: One 10 mL multiple-dose vial NDC 0002-7511-01 Five 3 mL single-patient-use KwikPen prefilled pen NDC 0002-8797-59 HUMALOG Mix75/25 KwikPen must never be shared between patients, even if the needle is changed. Patients using HUMALOG Mix75/25 vials must never share needles or syringes with another person.

Always use a new disposable syringe or needle for each injection to prevent contamination. The HUMALOG Mix75/25 KwikPen dials in 1 unit increments.

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 storage table below: a When stored at room temperature, HUMALOG Mix75/25 vial can only be used for a total of 28 days including both not in use (unopened) and in-use (opened) storage time. b When stored at room temperature, HUMALOG Mix75/25 KwikPen can only be used for a total of 10 days including both not in-use (unopened) and in-use (opened) storage time. Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) Not In-Use (Unopened) Room Temperature (up to 86°F [30°C]) In-Use (Opened) (see temperature below) 10 mL multiple-dose vial a Until expiration date 28 days 28 days Refrigerated or room temperature 3 mL single-patient-use KwikPen b prefilled pen Until expiration date 10 days 10 days Room temperature only (Do not refrigerate)

16.1How Supplied HUMALOG Mix75/25 (insulin lispro protamine and insulin lispro) injectable suspension is a white and cloudy suspension of 100 units/mL (U-100) of 75% insulin lispro protamine and 25% insulin lispro available as: One 10 mL multiple-dose vial NDC 0002-7511-01 Five 3 mL single-patient-use KwikPen prefilled pen NDC 0002-8797-59 HUMALOG Mix75/25 KwikPen must never be shared between patients, even if the needle is changed. Patients using HUMALOG Mix75/25 vials must never share needles or syringes with another person.

Always use a new disposable syringe or needle for each injection to prevent contamination. The HUMALOG Mix75/25 KwikPen dials in 1 unit increments.

📦 Storage and Handling 157 words ▾

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 storage table below: a When stored at room temperature, HUMALOG Mix75/25 vial can only be used for a total of 28 days including both not in use (unopened) and in-use (opened) storage time. b When stored at room temperature, HUMALOG Mix75/25 KwikPen can only be used for a total of 10 days including both not in-use (unopened) and in-use (opened) storage time. Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) Not In-Use (Unopened) Room Temperature (up to 86°F [30°C]) In-Use (Opened) (see temperature below) 10 mL multiple-dose vial a Until expiration date 28 days 28 days Refrigerated or room temperature 3 mL single-patient-use KwikPen b prefilled pen Until expiration date 10 days 10 days Room temperature only (Do not refrigerate)

📋 Description ~1 min read ▾

11 DESCRIPTION Insulin lispro is a rapid-acting 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.

HUMALOG Mix75/25 (insulin lispro protamine and insulin lispro) injectable suspension is a mixture of 75% insulin lispro protamine, an intermediate-acting human insulin analog, and 25% insulin lispro, a rapid-acting human insulin analog. Insulin lispro protamine suspension is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation. Insulin lispro has the following primary structure: HUMALOG Mix75/25 (insulin lispro protamine and insulin lispro) injectable suspension is a white and cloudy, sterile suspension for subcutaneous use.

Each mL of HUMALOG Mix75/25 contains 100 units of insulin lispro; dibasic sodium phosphate (2.0 mg), glycerin (16 mg), metacresol (1.76 mg), phenol (0.715 mg), protamine sulfate (0.28 mg), zinc oxide content adjusted to provide zinc ion (0.025 mg), and Water for Injection, USP. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid is added during manufacture to adjust the pH.

Primary Structure

💬 Information for Patients ~1 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 Mix75/25 KwikPen or Syringe Between Patients Advise patients using Humalog Mix75/25 vials or Humalog Mix75/25 KwikPen not to share needles, syringes, or KwikPen with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.1 )] .

Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of HUMALOG Mix75/25 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 [see Warnings and Precautions ( 5.3 )]. 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.

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 label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with HUMALOG Mix75/25.

Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see Warnings and Precautions ( 5.5 )] . Manufactured by: Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 Copyright © 1999, 2023, Eli Lilly and Company. All rights reserved.

LOG7525-0006-USPI-20230721

🧬 Pharmacokinetics 211 words ▾

12.3Pharmacokinetics Absorption — HUMALOG Mix75/25 has two phases of absorption. The early phase represents insulin lispro and its distinct characteristics of rapid onset. The late phase represents the prolonged absorption of insulin lispro protamine suspension.

In 31 healthy subjects given subcutaneous doses (0.3 unit/kg) of HUMALOG Mix75/25, the median peak serum concentration was 60 minutes (range: 30 minutes to 4 hours) after dosing. Identical results were found in patients with type 1 diabetes. The rapid absorption characteristics of HUMALOG are maintained with HUMALOG Mix75/25.

HUMALOG Mix75/25 has a more rapid absorption than HUMULIN 70/30, which has been confirmed in patients with type 1 diabetes. Metabolism — Human metabolism studies of HUMALOG Mix75/25 have not been conducted. However, studies in animals indicate that the metabolism of HUMALOG, the rapid-acting component of HUMALOG Mix75/25, is identical to that of regular human insulin.

Elimination — Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve. Specific Populations The effects of age, race, obesity, pregnancy, smoking, or renal or hepatic impairment on the pharmacokinetics of HUMALOG Mix75/25 have not been studied. Gender — Pharmacokinetic and pharmacodynamic comparisons between men and women administered HUMALOG Mix75/25 showed no gender differences.

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics In a glucose clamp study performed in 30 healthy subjects, the onset of action and glucose-lowering activity of HUMALOG, HUMALOG ® Mix50/50™, HUMALOG Mix75/25, and insulin lispro protamine suspension (ILPS) were compared ( see Figure 1 ). Graphs of mean glucose infusion rate versus time showed a distinct insulin activity profile for each formulation. The rapid onset of glucose-lowering activity characteristic of HUMALOG was maintained in HUMALOG Mix75/25.

The median maximum pharmacologic effect of HUMALOG Mix75/25 after administration of a 0.3 unit/kg dose to healthy subjects occurred at approximately 2 hours (range: 1-6 hours); glucose lowering activity was detectable for a median of 22 hours (range: 13 to 22 hours), which was the end of the clamp. In separate glucose clamp studies performed in healthy subjects, pharmacodynamics of HUMALOG Mix75/25 and HUMULIN ® 70/30 were assessed and are presented in Figure 2 . HUMALOG Mix75/25 has a duration of activity similar to that of HUMULIN 70/30.

Figures 1 and 2 should be considered only as representative examples since the time course of action of insulin and insulin analogs, may vary in different individuals or within the same individual. Figure 1: Mean Insulin Activity Versus Time Profiles After Injection of 0.3 units/kg of HUMALOG, HUMALOG Mix50/50, HUMALOG Mix75/25, or Insulin Lispro Protamine Suspension (ILPS) in 30 Healthy Subjects. Figure 2: Mean Insulin Activity Versus Time Profiles After Injection of 0.3 units/kg of HUMALOG Mix75/25 or HUMULIN 70/30 in Healthy Subjects.

Figure 1 Figure 2

🧪 Nonclinical Toxicology 203 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed with HUMALOG Mix75/25. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro (a component of HUMALOG Mix75/25) at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit insulin lispro/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 insulin lispro/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 insulin lispro/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 200 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed with HUMALOG Mix75/25. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro (a component of HUMALOG Mix75/25) at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit insulin lispro/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 insulin lispro/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 insulin lispro/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: 07/2023 PATIENT INFORMATION HUMALOG ® (HU-ma-log) Mix75/25™ (insulin lispro protamine and insulin lispro) injectable suspension, for subcutaneous use Do not share your HUMALOG Mix75/25 KwikPen, 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 Mix75/25? HUMALOG Mix75/25 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.

It is not known if HUMALOG Mix75/25 is safe and effective in children under 18 years of age. Who should not take HUMALOG Mix75/25? Do not take HUMALOG Mix75/25 if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to HUMALOG Mix75/25 or any of the ingredients in HUMALOG Mix75/25.

See the end of this Patient Information leaflet for a complete list of ingredients in Humalog Mix75/25. What should I tell my healthcare provider before taking Humalog Mix75/25? Before taking HUMALOG Mix75/25, tell your healthcare provider about all of 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 Mix75/25. are pregnant or plan to become pregnant. Talk with 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 Mix75/25.

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 Mix75/25, talk to your healthcare provider about low blood sugar and how to manage it. How should I take HUMALOG Mix75/25?

Read the Instructions for Use that comes with your HUMALOG Mix75/25. Take HUMALOG Mix75/25 exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much HUMALOG Mix75/25 to take and when to take it.

HUMALOG Mix75/25 starts acting fast. Inject HUMALOG Mix75/25 within 15 minutes before you eat a meal. 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.

Inject HUMALOG Mix75/25 under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms. Do not inject HUMALOG Mix75/25 into your vein (intravenously) or use in an insulin infusion pump. Change (rotate) your injection sites within the area you choose with 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 use the exact same spot for each injection. 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.

Do not mix HUMALOG Mix75/25 with other insulins or liquids. Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep HUMALOG Mix75/25 and all medicines out of the reach of children. Your dose of HUMALOG Mix75/25 may need to change because of a: change in physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take. What should I avoid while takin… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

VIAL INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE HUMALOG ® (HU-ma-log) Mix75/25™ (insulin lispro protamine and insulin lispro) injectable suspension, for subcutaneous use 10 mL multiple-dose vial (100 units per mL) Read this Instructions for Use before you start taking HUMALOG Mix75/25 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 Mix75/25 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 Mix75/25 dose Wash your hands with soap and water. Check the HUMALOG Mix75/25 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 Mix75/25 is easier to mix when it is at room temperature. After mixing HUMALOG Mix75/25, inject your dose right away.

If you wait to inject your dose, the insulin will need to be mixed again. Always use a new syringe and needle for each injection to help 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: Gently roll the vial between the palms of your hands at least 10 times. Step 2: Gently move the vial up and down (invert) at least 10 times.

Mixing is important to make sure you get the right dose. Humalog Mix75/25 should look white and cloudy after mixing. Do not use it if it looks clear or contains any lumps or particles.

Step 3: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper. Step 4: Wipe the Rubber Stopper with an alcohol swab. Step 5: 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 6: Push the needle through the Rubber Stopper of the vial.

Step 7: Push the Plunger all the way in. This puts air into the vial. Step 8: 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 Tip 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 9: 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 10: Pull the syringe out of the Rubber Stopper of the vial. Giving your HUMALOG Mix75/25 injection 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.

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 11: Choose your injection site. HUMALOG Mix75/25 is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms. Wipe the skin with an alcohol swab.

Let the injection site dry before you inject your dose. Step 12: Insert the needle in… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 140 words ▾

PACKAGE CARTON – HUMALOG Mix75/25 10 mL vial 1ct NDC 0002-7511-01 Humalog ® Mix75/25 TM (insulin lispro protamine and insulin lispro) injectable suspension 100 units per mL (U-100) For subcutaneous use only 10 mL multiple-dose vial Use only with a U-100 syringe Rx only U-100 www.humalog.com Lilly PACKAGE CARTON – HUMALOG Mix75/25 10 mL vial 1ct

PACKAGE CARTON – HUMALOG Mix75/25 KwikPen 5ct NDC 0002-8797-59 Humalog ® Mix75/25™ KwikPen ® (insulin lispro protamine and insulin lispro) injectable suspension 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 Mix75/25 KwikPen 5ct

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial00002-7511-01 7,610 Rx · $1,530,156
1 vial this page00002-7511-99 No Medicaid data
Drug total (last 4 qtrs): 7,610 Rx · 180,400 units · $1,530,156 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Humalog Mix 75-25 — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Humalog Mix 75-25. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.35M
Claims incl. refills
9K
Beneficiaries
5.5K
Spend / beneficiary
$428.96
Spend / claim
$261.22
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Humalog Mix75/25 (this brand).

Top reported reactions

Blood Glucose Increased36,991
Blood Glucose Decreased8,577
Visual Impairment5,287
Nausea4,826
Malaise3,942
Hypoglycaemia3,811
Fatigue3,733

Reporter sex

0 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization33,411
Death5,839
Life-threatening3,189
Disabling2,808
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9,345 2,676
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eli Lilly and Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00002-7511-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1815 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00002-7510-01 · Eli 00002-7516-59 · Eli →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.