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Humulin 70/30 Insulin human 100 [iU]/mL Injection, Suspension

by Eli Lilly and Company · 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8715-01) / 10 mL in 1 VIAL, MULTI-DOSE

NDC 00002-8715-01

🏷️ FDA NDC (as labeled) 0002-8715-01 billing pads the labeler segment with a zero

This package

Contains10 mL in 1 vial, multi-dose Cost per mL$4.26 NADAC Per package$42.58 / 10 ml Pack sizes2 compare ↓

Also priced by: Medicaid pays $6.91/unit · Part D plans $4.53/unit — full pricing hub ↓

Also comes in: 3 mL 00002-8715-17

OTC Brand On market Non-controlled

🗂️ Data synced Sep 10, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 0002-8715-01

Product NDC 0002-8715

11-digit billing NDC 00002871501

NCPDP billing unit ML — per mL (volume)

UNII 1Y17CTI5SR

Application # BLA019717

SPL Set ID e245e0c5-b2d6-418b-baa4-1c3324292885

Established class (EPC) Insulin

Chemical class Insulin

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1989-06-26

Route SUBCUTANEOUS

Dosage form INJECTION, SUSPENSION

Substance INSULIN HUMAN

GCN Seq No 016311

GCN 50001

HICL code 006215

Ingredient (HICL) Insulin Nph Hum/Reg Insulin Hm

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C4

Therapeutic class — intermediate (HIC2) Antihyperglycemics

HIC3 code C4G

Therapeutic class — specific (HIC3) Insulins

AHFS code 68:20.08.00

AHFS class Insulins

FDB label name HUMULIN 70-30 VIAL

FDB brand name Humulin 70-30

Legend status O — Over-the-counter (OTC) drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 0002-8715-01 — 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 → 00002-8715-01. 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.

🏭 Manufacturer & labeler

LabelerEli Lilly and Company

FDA applicationBLA019717 (BLA)

Labeler code00002

First marketedJun 1989

Product typeHuman Otc Drug

Portfolio192 products on file

🔎 All NDCs from Eli Lilly and Company

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.

🩺 Clinical

Label name HUMULIN 70-30 VIAL Ingredient Insulin Nph Hum/Reg Insulin Hm

📖 What it is MedlinePlus · NLM

Human insulin is used to control blood sugar in people who have type 1 diabetes (condition in which the body does not make insulin and therefore cannot control the amount of sugar in the blood) or in people who have type 2 diabetes (condition in which the blood sugar is too high because the body does not produce or use insulin normally) that cannot be controlled with oral medications alone. Human insulin is in a class of medications called hormones. Human insulin is used to take the place of insulin that is normally produced by the body. It works by helping move sugar from the blood into other...

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

16 mg / 1 mL UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
1.6 mg / 1 mL UNII GGO4Y809LO
Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
0.65 mg / 1 mL UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
0.241 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 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
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.
0.025 mg / 1 mL UNII J41CSQ7QDS
A mineral element that strengthens tablet structure and acts as a processing aid. Zinc helps bind ingredients together and may improve the medicine's stability during manufacturing and storage.

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.

💲 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	$4.258	$42.58 / 10 ml
Medicaid paysCMS SDUD · 12 mo	$6.91	$69.08 / 10 ml
Medicare drug plans payPart D · Q2 2026	$4.53	$45.32 / 10 ml
Medicare Part B allowsASP · J1815	No ASP payment limit on file for J1815 this quarter.

NADAC price history (per mL) — tap or hover for the price & month

▼ Down 70% over the last 13 months.

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)0002-8715-01

11-digit billing NDC00002-8715-01

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

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Humulin 70/30 100 [iU]/mLthis 00002-8715-01	Eli	1 vial	$4.258	—	Availability likely	—
Humulin N 100 [iU]/mL 00002-8315-01	Eli	1 vial	$4.267	—	Availability likely	+0%
Humulin 70/30 KwikPen 100 [iU]/mL 00002-8803-59	Eli	5 syringes	$9.034	—	Availability likely	+112%
Humulin N 100 [iU]/mL 00002-8805-59	Eli	5 syringes	$9.035	—	Availability likely	+112%
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	—

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

🏛️

1982

First FDA approval

Oct 1982

📍

2026

Currently FDA-listed

44 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

Afrezzainsulin human Humulin R U-100insulin human Humulin R U-500insulin human Myxredlininsulin human Novolin Rinsulin human

🔒 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00002-8715-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

72K

Units reimbursed last 4 qtrs

1.6M

Gross reimbursed last 4 qtrs

$10.76M

Avg / prescription

$149.40

Avg / unit

$6.9077

Latest quarter Q4 2025

15.9KRx

Medicaid pays / mL

$6.9077

gross reimbursed

NADAC / mL

$4.2580

acquisition cost

Spread

+$2.6497

+62% vs cost

What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

21% FFS 79% MCO

Fee-for-service · 15,255 Rx Managed care · 56,752 Rx

State Medicaid map

Units reimbursed · per 100k residents

27.8618

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Maryland 618 /100k

2 California 605 /100k

3 Illinois 587 /100k

4 Mississippi 577 /100k

5 Virginia 562 /100k

6 D.C. 504 /100k

7 Kentucky 503 /100k

8 Arkansas 464 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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 vial this page00002-8715-01 72,007 Rx · $10,757,553

1 vial00002-8715-17 22 Rx · $1,869

Drug total (last 4 qtrs): 72,029 Rx · 1,557,725 units · $10,759,421 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 Humulin 70-30 — 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 Humulin 70-30. 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

$5.66M

Claims incl. refills

41.6K

Beneficiaries

25.6K

Spend / beneficiary

$220.90

Spend / claim

$135.96

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00002-8715-01 You're viewing this	1 VIAL, MULTI-DOSE in 1 CARTON (0002-8715-01) / 10 mL in 1 VIAL, MULTI-DOSE	$4.26 / mL	$42.58	1989-06-26	Active
00002-8715-17	1 VIAL, MULTI-DOSE in 1 CARTON (0002-8715-17) / 3 mL in 1 VIAL, MULTI-DOSE	—	—	2011-04-09	Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00002-8715-01?

NDC 00002-8715-01 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 Humulin 70/30 Insulin human 100 [iU]/mL Injection, Suspension?

Bill NDC 00002-8715-01 — the 11-digit billing format is 00002871501. 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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. 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

🎯 Indications and Usage 56 words ▾

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 min read ▾

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 63 words ▾

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 63 words ▾

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 ~3 min read ▾

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…

🤒 Adverse Reactions ~1 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 )] . 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 ~1 min read ▾

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 ~2 min read ▾

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 ~1 min read ▾

All available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and effectiveness of HUMULIN 70/30 in pediatric patients have not been established.

🧓 Geriatric Use 57 words ▾

🆘 Overdosage 87 words ▾

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 ~1 min read ▾

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 34 words ▾

📦 How Supplied / Storage and Handling ~2 min read ▾

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.

The HUMULIN 70/30 KwikPen dials in 1 unit increments.

📦 Storage and Handling 169 words ▾

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from heat and light. Do not freeze.

📋 Description 196 words ▾

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 ~2 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 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.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diabetic ketoacidosis: A serious condition, mainly in people with diabetes, where the blood turns acidic because the body burns fat instead of sugar for energy.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glycosuria: Sugar (glucose) in the urine, which often happens when blood sugar is high.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

HbA1c: A blood test showing average blood sugar over the past two to three months; also called A1C or glycated hemoglobin.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

immunogenicity: The tendency of a medicine to make the body produce antibodies against it, which can affect how well it works or cause reactions.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 00002-8501-01 · Eli 00002-8797-59 · 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.

Humulin 70/30 Insulin human 100 [iU]/mL Injection, Suspension

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