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Humulin R Insulin human 100 [iU]/mL Injection, Solution — NDC 00002-0213-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humulin R Insulin human 100 [iU]/mL Injection, Solution — NDC 0002-0213-01 (Billing 00002-0213-01)

by Eli Lilly and Company · 1 VIAL, MULTI-DOSE in 1 CARTON / 3 mL in 1 VIAL, MULTI-DOSE

This is a package of Humulin R Insulin human 100 [iU]/mL Injection, Solution from Eli Lilly and Company, marketed since Jun 1983 and currently FDA-listed, this package's marketing is listed to end Dec 2026. It is this product's only package size.

NDC 00002-0213-01
🏷️ FDA NDC (as labeled) 0002-0213-01 billing pads the labeler segment with a zero
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0002-0213-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0002 labeler · 0213 product · 01 package
Package marketed since
Jun 20, 2023
Package marketing ended
Dec 15, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0002021301 6
Medicaid fills, this package
1,033 prescriptions in the last four reported quarters
FDA record last changed
Sep 17, 2026
⚠️
Other active recalls for Insulin Human (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0806-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0002-0213-01
Product NDC 0002-0213
11-digit billing NDC 00002021301
NCPDP billing unit ML — per mL (volume)
RxCUI 311034, 311036
UNII 1Y17CTI5SR
Application # BLA018780
SPL Set ID b519bd83-038c-4ec5-a231-a51ec5cc291f
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 1983-06-27
Marketing end 2026-12-15
Route PARENTERAL
Dosage form INJECTION, SOLUTION
Substance INSULIN HUMAN
Biologic (Purple Book) 351(a)

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

GCN Seq No 001723
GCN 11642
HICL code 000768
Ingredient (HICL) Insulin Regular, Human
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 R 100 UNIT/ML VIAL
FDB brand name Humulin R
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 001723
  • GCN: 11642
  • HICL (First Databank): 000768
  • AHFS class code: 68:20.08.00
  • RxCUI (RxNorm): 311034
Why two NDCs? The FDA registers this code as 0002-0213-01 — 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 → 00002-0213-01. 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.

RxNorm drug class

This medicine belongs to the Insulin class.

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

Clinical

Label name HUMULIN R 100 UNIT/ML VIAL Ingredient Insulin Regular, Human
📖 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 ↗

Supplement & herbal interactions

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $5.09 $15.28 / 3 ml
Medicare drug plans payPart D · Q2 2026 $4.54 $13.61 / 3 ml
Medicare Part B allowsASP · J1817 $3.062 / J1817 unit —
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)0002-0213-01
11-digit billing NDC00002-0213-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1817
DescriptorInsulin for administration through dme (i.e., insulin pump) per 50 units
Billing units / pkg6 units
How the units are derivedThis package is 3; the HCPCS unit is 50 UNITS, so one package = 6 billing units.
Medicare Part B spend (2026 (Q1))$7,997,475 · 28,262 claims · $282.98 per claim (all NDCs under J1817)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00002-0213-01 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 3 mL in 1 VIAL, MULTI-DOSE 2023-06-20 Dec 15, 2026 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Humulin R 100 [iU]/mL 00002-8215-01 Eli 1 vial $4.263 — Availability likely —
Humulin R 100 [iU]/mLthis 00002-0213-01 Eli 1 vial — — FDA listed —
Novolin R 100 [iU]/mL 00169-1833-02 Novo 1 vial — — FDA listed —
Humulin R 100 [iU]/mL 50090-0353-00 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.

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.
  • 2.5 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.
  • 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.
  • 0.015 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.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerEli Lilly and Company
FDA applicationBLA018780 (BLA)
Labeler code00002
First marketedJun 1983
Product typeHuman Otc Drug
Portfolio192 products on file

More NDCs from Eli Lilly and Company labeler code 00002

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

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 44 words ▾

1 INDICATIONS AND USAGE HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMULIN ® R is a short-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 ) Subcutaneous injection: inject subcutaneously 30 minutes before a meal into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

( 2.2 ) Intravenous infusion: administer intravenously ONLY under medical supervision at concentrations from 0.1 unit/mL to 1 unit/mL in infusion systems containing 0.9% Sodium Chloride Injection. ( 2.2 ) Individualize dose based on route of administration, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) HUMULIN R given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.

( 2.3 ) Do not mix with insulin preparations other than HUMULIN ® N. ( 2.5 )

2.1Important Administration Instructions Always check the insulin label before administration to confirm the correct insulin product is being used [see Warnings and Precautions ( 5.4 )] . Inspect HUMULIN R visually before use. It should appear clear and colorless. Do not use HUMULIN R if particulate matter or coloration is seen.

2.2Route of Administration Subcutaneous Injection Inject HUMULIN R subcutaneously approximately 30 minutes before meals into the thigh, upper arm, abdomen, 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 )] .

HUMULIN R may be diluted with Sterile Diluent for HUMULIN R for subcutaneous injection ONLY under medical supervision. Dilute one part HUMULIN R to nine parts diluent to yield a concentration one-tenth that of HUMULIN R (equivalent to U-10). Dilute one part HUMULIN R to one part diluent to yield a concentration one-half that of HUMULIN R (equivalent to U-50).

Diluted HUMULIN R may be used for 28 days when stored at 41°F (5°C) or for 14 days when stored at 86°F (30°C). Intravenous Administration Administer HUMULIN R intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to reduce the risk of hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 )] . For intravenous use, HUMULIN R should be used at concentrations from 0.1 unit/mL to 1 unit/mL in infusion systems containing 0.9% Sodium Chloride Injection.

Intravenous infusion bags prepared with HUMULIN R are stable when stored in a refrigerator (36° to 46°F [2° to 8°C]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.

2.3Dosing Instructions Individualize and adjust the dosage of HUMULIN R based on the route of administration, the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. HUMULIN R given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin. During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] .

Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (e.g., 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 ), Use in Specific Populations ( 8.6 , 8.7 )] . Dosage adjustment may be needed when changing from another insulin to HUMULIN R [see Warnings and Precautions ( 5.2 )] .

2.4Dosage Adjustment due to Drug Interactions Dosage adjustment may be needed when HUMULIN R is co-administered with certain drugs [see Drug Interactions ( 7 )] .

2.5Instructions for Mixing with Other Insulins for Subcutaneous Injection Do not mix HUMULIN R with insulin preparations other than HUMULIN N. To mix HUMULIN R and HUMULIN N, draw HUMULIN R int… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100), clear and colorless solution available as: 10 mL multiple-dose vial 3 mL multiple-dose vial Injection: 100 units/mL (U-100) is available as: 10 mL multiple-dose vial ( 3 ) 3 mL multiple-dose vial ( 3 )

⛔ Contraindications 64 words ▾

4 CONTRAINDICATIONS HUMULIN R is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] in patients with hypersensitivity to HUMULIN R or any of its excipients [see Warnings and Precautions ( 5.5 )] Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to HUMULIN R or any of its excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share needles or syringes with another person. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening.

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

( 5.4 ) Hypersensitivity Reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue HUMULIN R, monitor, and treat if indicated. ( 5.5 ) Hypokalemia: May be life-threatening.

Monitor potassium levels in patients at risk for 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 Needles or Syringes between Patients Patients using HUMULIN R 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, adjustments in concomitant anti-diabetic medications may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction of all insulins, including HUMULIN R. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place 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 R 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 site blood supply and temperature [see Clinical Pharmacology ( 12.2 )] . Other factors which may increase the risk of hypoglyce… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.3 )] Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypersensitivity [see Warnings and Precautions ( 5.5 )] Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with HUMULIN R include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, edema, pruritus, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of HUMULIN R. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Adverse reactions associated with insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy.

Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypersensitivity Reactions Severe allergic reactions may include anaphylaxis, generalized skin reactions, rash, angioedema, bronchospasm, hypotension, and shock. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in HUMULIN R.

Hypokalemia HUMULIN R can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Injection Site Reactions Injection site reactions may include injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass. Lipodystrophy Administration of insulin subcutaneously, including HUMULIN R, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see Dosage and Administration ( 2.2 )] .

Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site. Medication Errors Medication errors in which other insulins have been accidentally substituted for HUMULIN R have been identified during postapproval use.

Peripheral Edema Insulins, including HUMULIN R, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Weight Gain Weight gain can occur with insulins, including HUMULIN R, and has been attributed to the anabolic effects of insulin. Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.

The incidence of antibody formation with HUMULIN R is unknown.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with HUMULIN R 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 R is co-administered with these drugs.

Drugs that May Decrease the Blood Glucose Lowering Effect of HUMULIN R 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 R is co-administered with these drugs.

Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of HUMULIN R 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 R 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 R 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 R, 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 R on milk production.

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

8.4Pediatric Use HUMULIN R is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of HUMULIN R must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 )] .

8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN R has not been studied. Elderly patients using HUMULIN R may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions ( 5.3 )] .

8.6Renal Impairment The effect of renal impairment on the pharmacokinetics and pharmacodynamics of HUMULIN R has not been studied. Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN R dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3 )] .

8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of HUMULIN R has not been studied. Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN R dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3 )] .

🤰 Pregnancy ~1 min read ▾

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 58 words ▾

8.4Pediatric Use HUMULIN R is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of HUMULIN R must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 )] .

🧓 Geriatric Use 43 words ▾

8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN R has not been studied. Elderly patients using HUMULIN R may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions ( 5.3 )] .

🆘 Overdosage 85 words ▾

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

More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately [see Warnings and Precautions ( 5.3 , 5.6 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary activity of insulin, including HUMULIN R, is the regulation of glucose metabolism. Insulin lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

12.2Pharmacodynamics The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. With subcutaneous use, the pharmacologic effect of HUMULIN R begins approximately 30 minutes (range: 10 to 75 minutes) after administration of doses in the 0.05 to 0.4 units/kg range (Figure 1). The effect is maximal at approximately 3 hours (range: 20 minutes to 7 hours) and terminates after approximately 8 hours (range: 3 to 14 hours).

In a study that administered 50 and 100 units doses subcutaneously to obese subjects, mean time of termination of effect was prolonged to approximately 18 hours (range approximately 12-24 hours). Figure 1: Mean Insulin Activity Versus Time Profile After Subcutaneous Injection of HUMULIN R (0.3 unit/kg) in Healthy Subjects. With intravenous use, the pharmacologic effect of HUMULIN R begins at approximately 10 to 15 minutes and terminates at a median time of approximately 4 hours (range: 2 to 6 hours) after administration of doses in the range of 0.1 to 0.2 units/kg.

The intravenous administration of HUMULIN R was tested in 21 people with type 1 diabetes. During the 6-hour assessment phase patients received intravenous HUMULIN R at an initial dose of 0.5 units/hour, adjusted to maintain blood glucose concentrations near normoglycemia (100 to 160 mg/dL). The mean blood glucose levels during the assessment phase for patients on HUMULIN R therapy are summarized below in Table 2.

All patients achieved near normoglycemia during the 6-hour assessment phase. The average time (± SE) required to attain near normoglycemia was 161 ± 14 minutes for HUMULIN R. Table 2: Mean Blood Glucose Concentrations (mg/dL) during Intravenous Infusions of HUMULIN R a Results shown as mean ± Standard Deviation.

Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous a 0 220 ± 11 30 204 ± 17 60 193 ± 18 120 172 ± 28 180 153 ± 30 240 139 ± 24 300 131 ± 22 360 128 ± 18 Figure 1

12.3Pharmacokinetics Absorption — In healthy subjects given subcutaneous doses of HUMULIN R ranging from 0.05 to 0.4 unit/kg, mean peak serum levels occurred between 36 to 150 minutes after dosing. After subcutaneous administration of a single 12 unit dose (approximately 0.15 units/kg) to patients with type 1 diabetes, the median peak serum level occurred at approximately 2 hours (range: 20 minutes-6 hours). In a study that administered 50 units (0.4-0.6 unit/kg) and 100 units (0.8-1.3 unit/kg) doses subcutaneously to healthy obese subjects, median peak serum levels were prolonged to approximately 3 hours (range 1 to 8 hours).

The absolute bioavailability after a single subcutaneous injection of HUMULIN R ranges from 48% to 89% in the 0.1 to 0.3 unit/kg dose range. Distribution — When HUMULIN R is administered intravenously at doses of 0.1 or 0.2 unit/kg, the mean volume of distribution ranges between 0.32 to

0.67L/kg. 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. Excretion — After subcutaneous administration of HUMULIN R doses in the 0.05-0.4 unit/kg dose range, the median apparent half-life is approximately 1.5 hours (range: 40 minutes-7 hours).

Mean apparent half-life of HUMULIN R after subcutaneous administration of higher doses (50 and 100 units) to healthy obese subjects was approximately 3.6 hours (range= 1.6-8.6 hours). When administered intravenously, HUMULIN R had a mean half-life of approximately 20 minutes at a 0.1 unit/kg dose and 1 hour at a 0.2 unit… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action The primary activity of insulin, including HUMULIN R, is the regulation of glucose metabolism. Insulin lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied HUMULIN R injection is 100 units/mL (U-100), a clear and colorless solution available as: 10 mL multiple-dose vial NDC 0002-8215-01 3 mL multiple-dose vial NDC 0002-8215-17 3 mL multiple-dose vial NDC 0002-0213-01 Patients using HUMULIN R vials must never share needles or syringes with another person.

16.2Storage and Handling Protect from heat and light. Do not freeze. Do not use HUMULIN R after the expiration date printed on the label or if it has been frozen.

See Table 3 below for storage conditions. Table 3: Storage Conditions HUMULIN R Vials a a When stored at room temperature, HUMULIN R can only be used for a total of 31 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 3 mL multiple-dose vial 31 days Until expiration date 31 days 31 days Storage of Diluted HUMULIN R and Intravenous Infusion Preparations with HUMULIN R Diluted HUMULIN R for subcutaneous injection may be stored for 28 days when refrigerated at 36° to 46°F [2° to 8°C] or for 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )].

Intravenous infusion bags prepared with HUMULIN R may be stored for 48 hours when refrigerated at 36° to 46°F [2° to 8°C]. The prepared intravenous infusion bags may then be stored at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .

16.1How Supplied HUMULIN R injection is 100 units/mL (U-100), a clear and colorless solution available as: 10 mL multiple-dose vial NDC 0002-8215-01 3 mL multiple-dose vial NDC 0002-8215-17 3 mL multiple-dose vial NDC 0002-0213-01 Patients using HUMULIN R vials must never share needles or syringes with another person.

📦 Storage and Handling ~1 min read ▾

16.2Storage and Handling Protect from heat and light. Do not freeze. Do not use HUMULIN R after the expiration date printed on the label or if it has been frozen.

See Table 3 below for storage conditions. Table 3: Storage Conditions HUMULIN R Vials a a When stored at room temperature, HUMULIN R can only be used for a total of 31 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 3 mL multiple-dose vial 31 days Until expiration date 31 days 31 days Storage of Diluted HUMULIN R and Intravenous Infusion Preparations with HUMULIN R Diluted HUMULIN R for subcutaneous injection may be stored for 28 days when refrigerated at 36° to 46°F [2° to 8°C] or for 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )].

Intravenous infusion bags prepared with HUMULIN R may be stored for 48 hours when refrigerated at 36° to 46°F [2° to 8°C]. The prepared intravenous infusion bags may then be stored at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .

📋 Description 119 words ▾

11 DESCRIPTION Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and has the empirical formula C 257 H 383 N 65 O 77 S 6 with a molecular weight of 5.808 kDa. HUMULIN R (insulin human) injection is a short-acting human insulin for subcutaneous or intravenous use. HUMULIN R is a sterile, aqueous, clear, and colorless solution.

HUMULIN R contains 100 units of insulin human in each milliliter. Each milliliter of HUMULIN R also contains glycerin (16 mg), metacresol (2.5 mg), endogenous zinc (approximately 0.015 mg/100 units,) and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH.

The pH is 7.0 to 7.8.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Never Share Needles or Syringes between Patients Advise patients using HUMULIN R vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of HUMULIN R therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

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

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.2 )] . Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with HUMULIN R.

Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see Warnings and Precautions ( 5.5 )] . Literature Revised: June 2023 Manufactured by: Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 Copyright © 1997, 2023, Eli Lilly and Company. All rights reserved.

LINR100-0006-USPI-20230620

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption — In healthy subjects given subcutaneous doses of HUMULIN R ranging from 0.05 to 0.4 unit/kg, mean peak serum levels occurred between 36 to 150 minutes after dosing. After subcutaneous administration of a single 12 unit dose (approximately 0.15 units/kg) to patients with type 1 diabetes, the median peak serum level occurred at approximately 2 hours (range: 20 minutes-6 hours). In a study that administered 50 units (0.4-0.6 unit/kg) and 100 units (0.8-1.3 unit/kg) doses subcutaneously to healthy obese subjects, median peak serum levels were prolonged to approximately 3 hours (range 1 to 8 hours).

The absolute bioavailability after a single subcutaneous injection of HUMULIN R ranges from 48% to 89% in the 0.1 to 0.3 unit/kg dose range. Distribution — When HUMULIN R is administered intravenously at doses of 0.1 or 0.2 unit/kg, the mean volume of distribution ranges between 0.32 to

0.67L/kg. 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. Excretion — After subcutaneous administration of HUMULIN R doses in the 0.05-0.4 unit/kg dose range, the median apparent half-life is approximately 1.5 hours (range: 40 minutes-7 hours).

Mean apparent half-life of HUMULIN R after subcutaneous administration of higher doses (50 and 100 units) to healthy obese subjects was approximately 3.6 hours (range= 1.6-8.6 hours). When administered intravenously, HUMULIN R had a mean half-life of approximately 20 minutes at a 0.1 unit/kg dose and 1 hour at a 0.2 unit/kg dose.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. With subcutaneous use, the pharmacologic effect of HUMULIN R begins approximately 30 minutes (range: 10 to 75 minutes) after administration of doses in the 0.05 to 0.4 units/kg range (Figure 1). The effect is maximal at approximately 3 hours (range: 20 minutes to 7 hours) and terminates after approximately 8 hours (range: 3 to 14 hours).

In a study that administered 50 and 100 units doses subcutaneously to obese subjects, mean time of termination of effect was prolonged to approximately 18 hours (range approximately 12-24 hours). Figure 1: Mean Insulin Activity Versus Time Profile After Subcutaneous Injection of HUMULIN R (0.3 unit/kg) in Healthy Subjects. With intravenous use, the pharmacologic effect of HUMULIN R begins at approximately 10 to 15 minutes and terminates at a median time of approximately 4 hours (range: 2 to 6 hours) after administration of doses in the range of 0.1 to 0.2 units/kg.

The intravenous administration of HUMULIN R was tested in 21 people with type 1 diabetes. During the 6-hour assessment phase patients received intravenous HUMULIN R at an initial dose of 0.5 units/hour, adjusted to maintain blood glucose concentrations near normoglycemia (100 to 160 mg/dL). The mean blood glucose levels during the assessment phase for patients on HUMULIN R therapy are summarized below in Table 2.

All patients achieved near normoglycemia during the 6-hour assessment phase. The average time (± SE) required to attain near normoglycemia was 161 ± 14 minutes for HUMULIN R. Table 2: Mean Blood Glucose Concentrations (mg/dL) during Intravenous Infusions of HUMULIN R a Results shown as mean ± Standard Deviation.

Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous a 0 220 ± 11 30 204 ± 17 60 193 ± 18 120 172 ± 28 180 153 ± 30 240 139 ± 24 300 131 ± 22 360 128 ± 18 Figure 1

🧪 Nonclinical Toxicology 18 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and fertility studies were not performed in animals.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 15 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and fertility studies were not performed in animals.

📄 Patient Package Insert ~3 min read ▾

Humulin R U-100 Vial Patient Package Insert This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: June 2022 Patient Information Humulin ® (HU-mu-lin) R (insulin human) injection, for subcutaneous or intravenous use U-100 (100 units/mL) 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. What is Humulin R? Humulin R is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Who should not use Humulin R? Do not use Humulin R if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to human insulin or any of the ingredients in Humulin R. See the end of this Patient Information leaflet for a complete list of ingredients in Humulin R.

What should I tell my healthcare provider before using Humulin R? Before using Humulin R, tell your healthcare provider about all your medical conditions including, if you: have liver or kidney problems. take other medicines, especially ones called TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humulin R. 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 R may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using HUMULIN R.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Before you start using Humulin R, talk to your healthcare provider about low blood sugar and how to manage it. How should I use Humulin R?

Read the detailed Instructions for Use that comes with your Humulin R. Use Humulin R exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Humulin R to use and when to use it.

Use Humulin R 30 minutes before eating a meal. Know the type, strength, and amount of insulin you use. Do not change the type, or amount 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 insulin label each time you give your injection to make sure you are using the correct insulin. Inject Humulin R under the skin (subcutaneously) of your upper legs (thighs), upper arms, buttocks or stomach area (abdomen).

Do not inject Humulin R into your vein (intravenously). - Do not mix Humulin R with any other insulin except Humulin ® N. If Humulin R is mixed with Humulin N, Humulin R should be drawn into the syringe first. Inject immediately after mixing.

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. Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep Humulin R and all medicines out of reach of children. Your dose of Humulin R may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take What should I avoid while using Humulin R? While using Humulin R do not : drive or operate heavy machinery, until you know how Humulin R affects you. drink alcohol or use prescription or o… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Humulin R U-100 Vial Instructions for Use Instructions for Use Humulin ® (HU-mu-lin) R (insulin human) injection, for subcutaneous or intravenous use 3 mL or 10 mL multiple-dose vial (100 units/mL) Read the Instructions for Use before you start taking HUMULIN R and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your 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 3 mL or 10 mL multiple-dose HUMULIN ® R 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 the Dose Wash your hands with soap and water. Check the HUMULIN R 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 R 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 make sure the syringe needle is sterile and to 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: Check the insulin.

HUMULIN R solution should look clear and colorless. Do not use HUMULIN R if it looks cloudy, thick, slightly colored, or if you see particles in the solution. Step 2: If you are using a new HUMULIN R vial, flip off the plastic protective Cap, but do not remove the Rubber Stopper.

Step 3: Wipe the Rubber Stopper with an alcohol swab. Step 4: 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 5: Push the needle through the Rubber Stopper of the vial. Step 6: Push the Plunger all the way in. This puts air into the vial.

Step 7: 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. (Example Dose: 20 units Plunger is shown at 24 units) If there are air bubbles in the syringe, tap the syringe gently a few times to let any air bubbles rise to the top. Step 8: Slowly push the Plunger up until the tip reaches the line for your prescribed dose.

Check to make sure that you have the right dose. (Example Dose: 20 units shown) Step 9: Pull the syringe out of the vial's Rubber Stopper. If you use HUMULIN R with HUMULIN N: HUMULIN N is the only type of insulin that can be mixed with HUMULIN R.

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

Give your injection right away. Giving your 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 10: Choose your injection site.

HUMULIN R 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 11: Insert the needle into your skin. Step 12: Push down on the Plunger to inject your dose. The needle should stay… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 104 words ▾

PACKAGE CARTON – HUMULIN R U-100 Vial 10 mL 1ct NDC 0002-8215-01 100 units per mL (U-100) Humulin ® R REGULAR (insulin human) injection 10 mL multiple-dose vial Use only with a U-100 syringe For subcutaneous or intravenous use. U-100 www.lilly.com Lilly PACKAGE CARTON – HUMULIN R U-100 Vial 10 mL 1ct

PACKAGE CARTON – HUMULIN R U-100 Vial 3 mL 1ct NDC 0002-0213-01 100 units per mL (U-100) Humulin ® R REGULAR (insulin human) injection 3 mL multiple-dose vial Use only with a U-100 syringe For subcutaneous or intravenous use. U-100 www.lilly.com Lilly PACKAGE CARTON – HUMULIN R U-100 Vial 3 mL 1ct

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

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 this package alone, 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 – Q1 2026 · 5 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
1K
Units reimbursed last 4 qtrs
2.6K
Gross reimbursed last 4 qtrs
$13.1K
Avg / prescription
$12.65
Avg / unit
$5.0939
Latest quarter Q1 2026
102Rx
Fee-for-service vs managed care ⓘ
19% FFS 81% MCO
Fee-for-service · 195 Rx Managed care · 838 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 38 units · 0.7 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 225 units · 24.5 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 171 units · 2.4 per 100k residents MA California: 396 units · 1.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 10 units · 0.5 per 100k residents NE Missouri: no data reported MO Kentucky: 663 units · 14.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 11 units · 0.5 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 811 units · 11.4 per 100k residents TN North Carolina: 6 units · 0.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 89 units · 1.9 per 100k residents LA Mississippi: no data reported MS Alabama: 85 units · 1.7 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 61 units · 0.3 per 100k residents FL
Units reimbursed · per 100k residents
0.124.5
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 South Dakota 24.5 /100k
2 Kentucky 14.6 /100k
3 Tennessee 11.4 /100k
4 Massachusetts 2.4 /100k
5 Louisiana 1.9 /100k
6 Alabama 1.7 /100k
7 California 1.0 /100k
8 Minnesota 0.7 /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.

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

Medicare Part D (outpatient prescription) spending for Humulin R — 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 R. 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
$3.72M
Claims incl. refills
37.8K
Beneficiaries
26.5K
Spend / beneficiary
$140.54
Spend / claim
$98.45
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

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

Top reported reactions

Blood Glucose Increased4,680
Blood Glucose Decreased1,655
Hypoglycaemia1,003
Nausea823
Diarrhoea798
Dyspnoea792
Fall683

Age at onset

Neonate71
Infant8
Child12
Adolescent14
Adult1,081
Elderly1,045

Reporter sex

20,263 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization8,190
Death2,059
Disabling892
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,155 419
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Eli Lilly and Company has reported a marketing end date of 2026-12-15, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eli Lilly and Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1817 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00002-0152-01 · Eli 00002-0243-01 · 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.