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Humulin 70/30 Insulin human 100 [iU]/mL Injection, Suspension — NDC 0002-8715-17 (Billing 00002-8715-17)
This is a package of Humulin 70/30 Insulin human 100 [iU]/mL Injection, Suspension from Eli Lilly and Company, marketed since Jun 1989 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0002-8715-17 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0002 labeler · 8715 product · 17 package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0002871517 8
- FDA record last changed
- Sep 17, 2026
Other active recalls for Insulin Human (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 016311
- GCN: 50001
- HICL (First Databank): 006215
- AHFS class code: 68:20.08.00
- RxCUI (RxNorm): 106892
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 7, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00002-8715-01 0002-8715-01 Main listing | 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE | $4.26 / mL | $42.56 | 1989-06-26 | — | Active |
| 00002-8715-17 You're viewing this | 1 VIAL, MULTI-DOSE in 1 CARTON / 3 mL in 1 VIAL, MULTI-DOSE | — | — | 2011-04-09 | — | 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?
What NDC number is used to bill for this package of Humulin 70/30 Insulin human 100 [iU]/mL Injection, Suspension?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Humulin N 100 [iU]/mL 00002-8315-01 | Eli | 1 vial | $4.267 | — | Availability likely | — |
| Humulin N 100 [iU]/mL 00002-8805-59 | Eli | 5 syringes | $9.033 | — | Availability likely | — |
| Humulin 70/30 KwikPen 100 [iU]/mL 00002-8803-59 | Eli | 5 syringes | $9.035 | — | Availability likely | — |
| Humulin 70/30 100 [iU]/mLthis 00002-8715-17 | Eli | 1 vial | — | — | FDA listed | — |
| Novolin 70/30 100 [iU]/mL 00169-1837-02 | Novo | 1 vial | — | — | FDA listed | — |
| Novolin 70/30 100 [iU]/mL 50090-0403-00 | A-S | 1 vial | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Eli Lilly and Company labeler code 00002
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- Humalog Mix50/50 KwikPen Insulin lispro 100 [iU]/mL Injection, Suspension NDC 0002-8798-59
- Humalog KwikPen Insulin lispro 100 [iU]/mL Injection, Solution NDC 0002-8799-59
- Humulin 70/30 KwikPen Insulin human 100 [iU]/mL Injection, Suspension NDC 0002-8803-59
- Humulin N Insulin human 100 [iU]/mL Injection, Suspension NDC 0002-8805-59
- Humulin R U-500 KwikPen Insulin human 500 [iU]/mL Injection, Solution NDC 0002-8824-27
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE HUMULIN 70/30 is a fixed ratio insulin formulation indicated to improve glycemic control in adults with diabetes mellitus. HUMULIN ® 70/30 is a mixture of insulin isophane human, an intermediate-acting human insulin, and insulin human, a short-acting insulin human, indicated to improve glycemic control in adults with diabetes mellitus. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Only administer subcutaneously (in abdominal wall, thigh, upper arm, or buttocks). ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal.
( 2.2 ) See Full Prescribing Information for dosage adjustments due to drug interactions and patients with renal and hepatic impairment. ( 2.2 ) Administer approximately 30-45 minutes before a meal. ( 2.2 )
2.1Important Administration Instructions Inspect HUMULIN 70/30 visually before use. It should not contain particulate matter and should appear uniformly cloudy after mixing. Do not use HUMULIN 70/30 if particulate matter is seen.
Administer HUMULIN 70/30 subcutaneously into the abdominal wall, thigh, upper arm, or buttocks. Rotate injection sites 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 HUMULIN 70/30 KwikPen dials in 1 unit increments. Use HUMULIN 70/30 KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose. Do not administer HUMULIN 70/30 intravenously and do not use in an insulin infusion pump.
Do not mix HUMULIN 70/30 with any other insulins or diluents.
2.2Dosage Information Inject HUMULIN 70/30 subcutaneously approximately 30-45 minutes before a meal. The proportion of rapid acting and long acting insulin is fixed in a premixed insulin such as HUMULIN 70/30. Independent adjustment of the basal or prandial dose is not possible when using a premixed insulin.
Individualize and adjust the dosage of HUMULIN 70/30 based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. 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 )] . During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] .
HUMULIN 70/30 dose requirements may change with changes in level of physical activity, meal patterns (i.e., macronutrient content or timing of food intake), during major illness, or with some coadministered drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 ), and Use in Specific Populations ( 8.6 , 8.7 )] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injectable suspension: 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), white and cloudy suspension available as: 10 mL multiple-dose vial 3 mL single-patient-use HUMULIN 70/30 KwikPen prefilled pen Injectable suspension 100 units/mL (U-100) available as: 10 mL multiple-dose vial ( 3 ) 3 mL single-patient-use HUMULIN ® 70/30 KwikPen ® prefilled pen ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS HUMULIN 70/30 is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )], and In patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients [see Warnings and Precautions ( 5.5 )] . During episodes of hypoglycemia. ( 4 ) In patients with hypersensitivity to HUMULIN 70/30 or any of its excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Never share a HUMULIN 70/30 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.
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.
( 5.4 ) Hypersensitivity Reactions : May be life-threatening. Discontinue HUMULIN 70/30, 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 )
5.1Never Share a HUMULIN 70/30 KwikPen or Syringe Between Patients HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 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 HUMULIN 70/30. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient 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 patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, 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 HUMULIN 70/30 may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection sit… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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 )] . The following additional adverse reactions have been identified during post-approval use of HUMULIN 70/30. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Adverse reactions observed with insulin therapy include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain, and edema. ( 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. Allergic Reactions Some patients taking HUMULIN 70/30 have experienced erythema, local edema, and pruritus at the site of injection.
These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions ( 5.5 )] . Peripheral Edema Some patients taking HUMULIN 70/30 have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy Administration of insulin subcutaneously, including HUMULIN 70/30, 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.
Weight gain Weight gain has occurred with insulins, including HUMULIN 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria. Immunogenicity Development of antibodies that react with human insulin have been observed with all insulins, including HUMULIN 70/30.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with HUMULIN 70/30 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 HUMULIN 70/30 is co-administered with these drugs.
Drugs that May Decrease the Blood Glucose Lowering Effect of HUMULIN 70/30 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 HUMULIN 70/30 is co-administered with these drugs.
Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of HUMULIN 70/30 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 HUMULIN 70/30 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 HUMULIN 70/30 is co-administered with these drugs. Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. ( 7 ) Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent.
( 5.3 , 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and 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). Animal reproduction studies were not performed.
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 While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
All available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size.
8.2Lactation Risk Summary Available data from published literature suggests that exogenous human insulin products, including HUMULIN 70/30, 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 HUMULIN 70/30 on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HUMULIN 70/30 and any potential adverse effects on the breastfed child from HUMULIN 70/30 or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of HUMULIN 70/30 in pediatric patients have not been established.
8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3 )] . Patients with advanced age using any insulin, including HUMULIN 70/30, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see Warnings and Precautions ( 5.3 )] .
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3 )] . Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN 70/30 dose adjustment and more frequent blood glucose monitoring.
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3 )] . Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN 70/30 dose adjustment and more frequent blood glucose monitoring.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and 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). Animal reproduction studies were not performed.
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 While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
All available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of HUMULIN 70/30 in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3 )] . Patients with advanced age using any insulin, including HUMULIN 70/30, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see Warnings and Precautions ( 5.3 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 )] . Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level 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 ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action HUMULIN 70/30 lowers 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 HUMULIN 70/30 combines an intermediate-acting insulin with the more rapid onset of action of regular human insulin. In healthy males (n=18) given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the pharmacologic effect began at approximately 50 minutes (range: 30 to 90 minutes) ( see Figure 1 ). The effect was maximal at approximately 3.5 hours (range: 1.5 to 6.5 hours) and the mean duration of action was relatively long (approximately 23 hours; range: 18-24 hours).
Figure 1 should be considered only as a representative example since the time course of action of insulin may vary in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, physical activity level, and other variables [see Warnings and Precautions ( 5.3 )] . Figure 1: Mean Insulin Activity Versus Time Profiles After Subcutaneous Injection of HUMULIN 70/30 or HUMULIN ® R U‑100 (0.3 unit/kg) in Healthy Subjects.
Figure 1
12.3Pharmacokinetics Absorption — In healthy male subjects given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the mean peak serum concentration occurred at 2.2 hours (range: 1 to 5 hours) after dosing. Metabolism — The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of 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, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN 70/30 have not been studied.
🧬 Mechanism of Action ▾
12.1Mechanism of Action HUMULIN 70/30 lowers 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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied HUMULIN 70/30 (insulin isophane human and insulin human) injectable suspension is 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), a white and cloudy suspension available as: 10 mL multiple-dose vial NDC 0002-8715-01 (HI-710) 5 x 3 mL single-patient-use HUMULIN 70/30 KwikPen NDC 0002-8803-59 (HP-8803) Each prefilled HUMULIN 70/30 KwikPen is for use by a single patient. HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person.
The HUMULIN 70/30 KwikPen dials in 1 unit increments.
16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from heat and light. Do not freeze.
Do not use if it has been frozen. See Table 2 below for storage conditions. Table 2: Storage Conditions for HUMULIN 70/30 Vials and Pens a When stored at room temperature, HUMULIN 70/30 vial can only be used for a total of 31 days including both not in-use (unopened) and in-use (opened) storage time. b When stored at room temperature, HUMULIN 70/30 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) In-use (Opened) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) 10 mL multiple-dose vial a 31 days Until expiration date 31 days 31 days 3 mL single-patient-use HUMULIN 70/30 KwikPen b 10 days Until expiration date 10 days Do not refrigerate.
16.1How Supplied HUMULIN 70/30 (insulin isophane human and insulin human) injectable suspension is 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), a white and cloudy suspension available as: 10 mL multiple-dose vial NDC 0002-8715-01 (HI-710) 5 x 3 mL single-patient-use HUMULIN 70/30 KwikPen NDC 0002-8803-59 (HP-8803) Each prefilled HUMULIN 70/30 KwikPen is for use by a single patient. HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person.
The HUMULIN 70/30 KwikPen dials in 1 unit increments.
📦 Storage and Handling ▾
16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from heat and light. Do not freeze.
Do not use if it has been frozen. See Table 2 below for storage conditions. Table 2: Storage Conditions for HUMULIN 70/30 Vials and Pens a When stored at room temperature, HUMULIN 70/30 vial can only be used for a total of 31 days including both not in-use (unopened) and in-use (opened) storage time. b When stored at room temperature, HUMULIN 70/30 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) In-use (Opened) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) 10 mL multiple-dose vial a 31 days Until expiration date 31 days 31 days 3 mL single-patient-use HUMULIN 70/30 KwikPen b 10 days Until expiration date 10 days Do not refrigerate.
📋 Description ▾
11 DESCRIPTION Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C 257 H 383 N 65 O 77 S 6 with a molecular weight of 5.808 kDa. HUMULIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% insulin isophane human suspension, an intermediate-acting insulin, and 30% insulin human injection, a short-acting insulin.
HUMULIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection. HUMULIN 70/30 is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of HUMULIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.24 mg), zinc oxide content adjusted to provide 0.025 mg zinc ion, and Water for Injection.
The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a HUMULIN 70/30 KwikPen or Syringe Between Patients Advise patients that they must never share a HUMULIN 70/30 KwikPen with another person, even if the needle is changed. Advise patients using HUMULIN 70/30 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 HUMULIN 70/30 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 )] . Inform patients that accidental mix-ups between insulin products have been reported. Instruct patients to always carefully check that they are administering the correct insulin (e.g., by checking the insulin label before each injection) to avoid medication errors between HUMULIN 70/30 and other insulins.
Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with HUMULIN 70/30. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] . ____________ HUMULIN ® and HUMULIN ® 70/30 KwikPen ® are trademarks of Eli Lilly and Company. Literature revised December 2025 Manufactured by: Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 Copyright © 1992, 2025, Eli Lilly and Company.
All rights reserved. LIN7030-0007-USPI-20251204
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption — In healthy male subjects given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the mean peak serum concentration occurred at 2.2 hours (range: 1 to 5 hours) after dosing. Metabolism — The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of 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, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN 70/30 have not been studied.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics HUMULIN 70/30 combines an intermediate-acting insulin with the more rapid onset of action of regular human insulin. In healthy males (n=18) given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the pharmacologic effect began at approximately 50 minutes (range: 30 to 90 minutes) ( see Figure 1 ). The effect was maximal at approximately 3.5 hours (range: 1.5 to 6.5 hours) and the mean duration of action was relatively long (approximately 23 hours; range: 18-24 hours).
Figure 1 should be considered only as a representative example since the time course of action of insulin may vary in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, physical activity level, and other variables [see Warnings and Precautions ( 5.3 )] . Figure 1: Mean Insulin Activity Versus Time Profiles After Subcutaneous Injection of HUMULIN 70/30 or HUMULIN ® R U‑100 (0.3 unit/kg) in Healthy Subjects.
Figure 1
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and fertility studies were not performed in animals. Biosynthetic human insulin was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis assays.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and fertility studies were not performed in animals. Biosynthetic human insulin was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis assays.
📄 Patient Package Insert ▾
PATIENT INFORMATION HUMULIN ® (HU-mu-lin) 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use Do not share your HUMULIN 70/30 KwikPen 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 HUMULIN 70/30?
HUMULIN 70/30 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus. Who should not use HUMULIN 70/30? Do not use HUMULIN 70/30 if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to HUMULIN 70/30 or any of the ingredients in HUMULIN 70/30.
Before using HUMULIN 70/30, tell your healthcare provider about all your medical conditions including, if you: have liver or kidney problems. take any other medicines, especially ones commonly called TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with HUMULIN 70/30. are pregnant, planning 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 breast-feeding or plan to breastfeed.
HUMULIN 70/30 may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using HUMULIN 70/30. are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements. Before you start using HUMULIN 70/30, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use HUMULIN 70/30? Read the Instructions for Use that come with your HUMULIN 70/30. Use HUMULIN 70/30 exactly as your healthcare provider tells you to.
HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. 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. Know the type and strength of insulin you use.
Do not change the type of insulin you use 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 use different types of insulin. Check your blood sugar levels.
Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. Do not share your HUMULIN 70/30 KwikPen 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.
Your HUMULIN 70/30 dose may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet. What should I avoid while using HUMULIN 70/30? While using HUMULIN 70/30 do not: drive or operate heavy machinery, until you know how HUMULIN 70/30 affects you. drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of HUMULIN 70/30? HUMULIN 70/30 may cause serious side effects that can lead to death, including: low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger. serious allergic reaction (whole body reaction).
Get medical help right away, if you have any of these symptoms of an allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, or sweating. low potassium in your blood (hypokalemia). heart fa… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
VIAL INSTRUCTIONS FOR USE Instructions for Use HUMULIN ® (HU-mu-lin) 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use 10 mL multiple-dose vial (100 units/mL) Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get a new HUMULIN 70/30 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 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 10 mL multiple-dose HUMULIN 70/30 vial a U-100 insulin syringe and needle 2 alcohol swabs 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 HUMULIN 70/30 dose: Wash your hands with soap and water. Check the HUMULIN 70/30 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. Do not use HUMULIN 70/30 past the expiration date printed on the label or 31 days after you first use it. Always use a new syringe or needle for each injection to help ensure sterility and prevent 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: Carefully invert the vial at least 10 times. Mixing is important to make sure you get the right dose. Humulin 70/30 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: Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger 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 tip is a few units past the line for your prescribed dose.
If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top. (Example Dose: 20 units Plunger is shown at 24 units) Step 9: Slowly push the Plunger up until the 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 vial's Rubber Stopper. Giving your HUMULIN 70/30 injection: Inject your insulin exactly as your healthcare provider has shown you. 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.
HUMULIN 70/30 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 into your skin. Step 13: Push down on the Plunger to inject your dose. The needle should stay in your skin for at least 5 seconds to make sure you have injected all of your insulin dose.
Step 14: Pull the needle out of your skin. If you see blood after you take the needle out of your skin, press the injection site with a… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE CARTON – HUMULIN 70/30 Vial 10 mL NDC 0002-8715-01 100 units per mL (U-100) Humulin ® 70/30 (insulin isophane human and insulin human) injectable suspension 10 mL multiple-dose vial Use only with a U-100 syringe For subcutaneous use only. U-100 www.lilly.com Lilly PACKAGE CARTON – HUMULIN 70/30 Vial 10 mL 1ct
PACKAGE LABEL – Humulin 7030 KwikPen 3mL 5 x 3 mL prefilled pens NDC 0002-8803-59 HP-8803 Humulin ® 70/30 KwikPen ® (insulin isophane human and insulin human) injectable suspension For Single Patient Use Only Dispense in this sealed carton Read Insulin Delivery Device Instructions for Use For subcutaneous use only. prefilled insulin delivery device 100 units per mL (U-100) Needles not included This device is suitable for use with Becton, Dickinson and Company's insulin pen needles. Lilly PACKAGE LABEL – Humulin 7030 KwikPen 3mL
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |