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Humulin N Insulin human 100 [iU]/mL Injection, Suspension — NDC 00002-8315-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humulin N Insulin human 100 [iU]/mL Injection, Suspension — NDC 0002-8315-99 (Billing 00002-8315-99)

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

This is a package of Humulin N Insulin human 100 [iU]/mL Injection, Suspension from Eli Lilly and Company, marketed since Jun 1983 and currently FDA-listed.

NDC 00002-8315-99
🏷️ FDA NDC (as labeled) 0002-8315-99 billing pads the labeler segment with a zero
This package
Contains10 mL in 1 vial, multi-dose Pack sizes3 compare ↓
Product page 00002-8315-01 Also comes in: 10 mL 0002-8315-01 3 mL 0002-8315-17
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 0002-8315-99 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0002 labeler · 8315 product · 99 package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0300028315019
FDA record last changed
Jul 24, 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) 0002-8315-99
Product NDC 0002-8315
11-digit billing NDC 00002831599
RxCUI 311026, 311028, 847199, 1654862
UNII 1Y17CTI5SR
UPC 0300028315019
Application # BLA018781
SPL Set ID f6edd793-440b-40c2-96b5-c16133b7a921
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
Route SUBCUTANEOUS
Dosage form INJECTION, SUSPENSION
Substance INSULIN HUMAN
Biologic (Purple Book) 351(a)

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

GPI-14 27104020001805
GPI class HumuLIN N
Quick answers
  • GPI-14 (Medi-Span): 27104020001805
  • RxCUI (RxNorm): 311026
Why two NDCs? The FDA registers this code as 0002-8315-99 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00002-8315-99. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 mL 3 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00002-8315-01 0002-8315-01 Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE $4.27 / mL $42.67 1983-06-27 — Active
00002-8315-17 0002-8315-17 1 VIAL, MULTI-DOSE in 1 CARTON / 3 mL in 1 VIAL, MULTI-DOSE $14.29 / mL $42.88 2010-06-24 — Active
00002-8315-99 You're viewing this 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE — — 1983-06-27 — Active

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

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Humulin N Insulin human 100 [iU]/mL Injection, Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Humulin 70/30 100 [iU]/mL 00002-8715-01 Eli 1 vial $4.256 — Availability likely —
Humulin N 100 [iU]/mL 00002-8805-59 Eli 5 syringes $9.033 — Availability likely —
Humulin 70/30 KwikPen 100 [iU]/mL 00002-8803-59 Eli 5 syringes $9.035 — Availability likely —
Humulin N 100 [iU]/mLthis 00002-8315-99 Eli 1 vial — — FDA listed —
Novolin N 100 [iU]/mL 00169-1834-02 Novo 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.
  • 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.
  • 0.35 mg / 1 mL UNII 0DE9724IHC
    Protamine sulfate is a protein derived from fish sperm that acts as a binder and stabilizer in medications. It helps hold tablet ingredients together and can improve the stability of certain drug formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 3.78 mg / 1 mL UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • 0.035 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.

Manufacturer & labeler

LabelerEli Lilly and Company
FDA applicationBLA018781 (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 N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. HUMULIN ® N is an intermediate-acting human insulin indicated to improve glycemic control in adult and pediatric patients 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). ( 2.2 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal.

( 2.3 ) See Full Prescribing Information for dosage adjustments due to drug interactions and patients with renal and hepatic impairment. ( 2.3 , 2.4 ) May use with a meal-time insulin if indicated. ( 2.4 )

2.1Important Administration Instructions Inspect HUMULIN N visually before use. It should not contain particulate matter and should appear uniformly cloudy after mixing. Do not use HUMULIN N if particulate matter is seen. Use HUMULIN N KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose.

2.2Route of Administration HUMULIN N should only be administered subcutaneously. Administer in the subcutaneous tissue of 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 )] . During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] . The HUMULIN N KwikPen dials in 1 unit increments.

Do not administer HUMULIN N intravenously and do not use HUMULIN N in an insulin infusion pump.

2.3Dosage Information Individualize and adjust the dosage of HUMULIN N 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 )] .

2.4Dosage Adjustment due to Drug Interactions Dosage adjustment may be needed when HUMULIN N is coadministered with certain drugs [see Drug Interactions ( 7 )]. Dosage adjustment may be needed when changing from another insulin to HUMULIN N [see Warnings and Precautions ( 5.2 )] . Instructions for Mixing with Other Insulins HUMULIN N may be used with a prandial insulin if indicated.

HUMULIN N may be mixed with HUMULIN R or HUMALOG before injection. If HUMULIN N is mixed with HUMULIN R, HUMULIN R should be drawn into the syringe first. Injection should occur immediately after mixing.

If HUMULIN N is mixed with HUMALOG, HUMALOG should be drawn into the syringe first. Injection should occur immediately after mixing.

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS Injectable suspension: 100 units/mL (U-100) white and cloudy suspension available as: 10 mL multiple-dose vial 3 mL single-patient-use HUMULIN N KwikPen prefilled pen Injectable suspension: 100 units/mL (U-100) available as: 10 mL multiple-dose vial ( 3 ) 3 mL single-patient-use HUMULIN ® N KwikPen ® prefilled pen ( 3 )

⛔ Contraindications 64 words ▾

4 CONTRAINDICATIONS HUMULIN N is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] , and In patients who have had hypersensitivity reactions to HUMULIN N or any of its excipients [see Warnings and Precautions ( 5.5 )] . During episodes of hypoglycemia. ( 4 ) In patients with hypersensitivity to HUMULIN N or any of its excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share a HUMULIN N 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 N, 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 N KwikPen or Syringe Between Patients HUMULIN N KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN N 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 N. 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 N 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 temperat… [Excerpted — this section continues on DailyMed.]

🤒 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 N. 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 HUMULIN N 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 N 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 N 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 N, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.2 )] 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 N, 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 N.

🔄 Drug Interactions ~1 min read ▾

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

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

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

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

8.4Pediatric Use HUMULIN N is indicated to improve glycemic control in pediatric patients with diabetes mellitus.

8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN N has not been studied [see Clinical Pharmacology ( 12.3 )] . Patients with advanced age using any insulin, including HUMULIN N, 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 N 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 N dose adjustment and more frequent blood glucose monitoring.

8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of HUMULIN N 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 N dose adjustment and more frequent blood glucose monitoring.

🤰 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 17 words ▾

8.4Pediatric Use HUMULIN N is indicated to improve glycemic control in pediatric patients with diabetes mellitus.

🧓 Geriatric Use 57 words ▾

8.5Geriatric Use The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN N has not been studied [see Clinical Pharmacology ( 12.3 )] . Patients with advanced age using any insulin, including HUMULIN N, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see Warnings and Precautions ( 5.3 )] .

🆘 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 ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action HUMULIN N 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 N is an intermediate-acting insulin with a slower onset of action and a longer duration of activity than that of regular human insulin. In a study in which healthy subjects (n=16) received subcutaneous injections of HUMULIN N (0.4 unit/kg) on 4 occasions, the median maximum effect occurred at 6.5 hours (range: 2.8 to 13 hours). In this study, insulin activity was measured by the rate of glucose infusions.

The time course of action of insulin, such as HUMULIN N may vary in different individuals or within the same individual. The parameters of HUMULIN N activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity 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 Profile After Subcutaneous Injection of HUMULIN N (0.4 unit/kg) in Healthy Subjects. Figure 1

12.3Pharmacokinetics Absorption — In healthy subjects given subcutaneous doses of HUMULIN N (0.4 unit/kg), median peak serum concentration of insulin occurred at approximately 4 hours (range: 1 to 12 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.

In healthy subjects given subcutaneous doses of HUMULIN N (0.4 unit/kg), the mean apparent half-life was approximately 4.4 hours (range: 1-84 hours). Specific Populations The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN N have not been studied.

🧬 Mechanism of Action 34 words ▾

12.1Mechanism of Action HUMULIN N lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

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

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied HUMULIN N (insulin isophane human) injectable suspension, 100 units/mL (U-100), is a white and cloudy suspension available as: 10 mL multiple-dose vial NDC 0002-8315-01 (HI-310) 5 x 3 mL single-patient-use HUMULIN N KwikPen NDC 0002-8805-59 (HP-8805) Each prefilled HUMULIN N KwikPen is for use by a single patient. HUMULIN N KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN N vials must never share needles or syringes with another person.

The HUMULIN N 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 N Vials and Pens a When stored at room temperature, HUMULIN N 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 N KwikPen can only be used for a total of 14 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 N KwikPen b 14 days Until expiration date 14 days Do not refrigerate.

16.1How Supplied HUMULIN N (insulin isophane human) injectable suspension, 100 units/mL (U-100), is a white and cloudy suspension available as: 10 mL multiple-dose vial NDC 0002-8315-01 (HI-310) 5 x 3 mL single-patient-use HUMULIN N KwikPen NDC 0002-8805-59 (HP-8805) Each prefilled HUMULIN N KwikPen is for use by a single patient. HUMULIN N KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN N vials must never share needles or syringes with another person.

The HUMULIN N 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.

Do not use if it has been frozen. See Table 2 below for storage conditions. Table 2: Storage Conditions for HUMULIN N Vials and Pens a When stored at room temperature, HUMULIN N 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 N KwikPen can only be used for a total of 14 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 N KwikPen b 14 days Until expiration date 14 days Do not refrigerate.

📋 Description 171 words ▾

11 DESCRIPTION Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli . Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane 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 N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N 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 (0.35 mg), zinc oxide content adjusted to provide 0.035 mg zinc ion, and Water for Injection.

The pH is 7.0 to 7.5. 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 N KwikPen or Syringe Between Patients Advise patients that they must never share a HUMULIN N KwikPen with another person, even if the needle is changed. Advise patients using HUMULIN N 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 N 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 N and other insulins.

Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with HUMULIN N. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] . ____________ HUMULIN ® and HUMULIN ® N 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 © 1997, 2025, Eli Lilly and Company.

All rights reserved. LINN-0008-USPI-20251219

🧬 Pharmacokinetics 134 words ▾

12.3Pharmacokinetics Absorption — In healthy subjects given subcutaneous doses of HUMULIN N (0.4 unit/kg), median peak serum concentration of insulin occurred at approximately 4 hours (range: 1 to 12 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.

In healthy subjects given subcutaneous doses of HUMULIN N (0.4 unit/kg), the mean apparent half-life was approximately 4.4 hours (range: 1-84 hours). Specific Populations The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN N have not been studied.

🧬 Pharmacodynamics 173 words ▾

12.2Pharmacodynamics HUMULIN N is an intermediate-acting insulin with a slower onset of action and a longer duration of activity than that of regular human insulin. In a study in which healthy subjects (n=16) received subcutaneous injections of HUMULIN N (0.4 unit/kg) on 4 occasions, the median maximum effect occurred at 6.5 hours (range: 2.8 to 13 hours). In this study, insulin activity was measured by the rate of glucose infusions.

The time course of action of insulin, such as HUMULIN N may vary in different individuals or within the same individual. The parameters of HUMULIN N activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity 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 Profile After Subcutaneous Injection of HUMULIN N (0.4 unit/kg) in Healthy Subjects. Figure 1

🧪 Nonclinical Toxicology 43 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and fertility studies were not performed in animals. Biosynthetic human insulin was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis assays.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 40 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and fertility studies were not performed in animals. Biosynthetic human insulin was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis assays.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION HUMULIN ® (HU-mu-lin) N (insulin isophane human) injectable suspension, for subcutaneous use Do not share your HUMULIN N KwikPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. What is HUMULIN N?

HUMULIN N 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 N? Do not use HUMULIN N if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to HUMULIN N or any of the ingredients in HUMULIN N.

Before using HUMULIN N, tell your healthcare provider about all your medical conditions including, if you: have liver or kidney problems. take any other medicines, especially ones commonly called TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with HUMULIN N. 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 N may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using HUMULIN N. are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements. Before you start using HUMULIN N, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use HUMULIN N? Read the Instructions for Use that come with your HUMULIN N. Use HUMULIN N exactly as your healthcare provider tells you to.

HUMULIN N is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the exact same spot for each injection.

Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Know the type and strength of insulin you use.

Do not change the type of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin. Check your blood sugar levels.

Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. Do not share your HUMULIN N KwikPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Your HUMULIN N dose may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet. What should I avoid while using HUMULIN N? While using HUMULIN N do not: drive or operate heavy machinery, until you know how HUMULIN N affects you. drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of HUMULIN N? HUMULIN N may cause serious side effects that can lead to death, including: low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger. serious allergic reaction (whole body reaction).

Get medical help right away, if you have any of these symptoms of an allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, or sweating. low potassium in your blood (hypokalemia). heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with HUMULIN N may cause hea… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

VIAL INSTRUCTIONS FOR USE Instructions for Use HUMULIN ® (HU-mu-lin) N (insulin isophane human) injectable suspension, for subcutaneous use 10 mL multiple-dose vial (100 units/mL) Read the Instructions for Use before you start taking HUMULIN N and each time you get a new HUMULIN N vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. Supplies needed to give your injection: a 10 mL multiple-dose HUMULIN N vial a U-100 insulin syringe and needle 2 alcohol swabs 1 sharps container for throwing away used needles and syringes.

See “Disposing of used needles and syringes” at the end of these instructions. Vial Syringe Preparing your HUMULIN N dose: Wash your hands with soap and water. Check the HUMULIN N 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 N past the expiration date printed on the label or 31 days after you first use it. Always use a new syringe or needle for each injection to help ensure sterility and prevent blocked needles.

Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them. Step 1: Gently roll the vial between the palms of your hands at least 10 times.

Step 2: Carefully invert the vial at least 10 times. Mixing is important to make sure you get the right dose. Humulin N should look white and cloudy after mixing.

Do not use it if it looks clear or contains any lumps or particles. Step 3: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper. Step 4: Wipe the Rubber Stopper with an alcohol swab.

Step 5: Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose. (Example Dose: 20 units shown) Step 6: Push the needle through the Rubber Stopper of the vial.

Step 7: Push the plunger all the way in. This puts air into the vial. Step 8: Turn the vial and syringe upside down and slowly pull the Plunger down until the tip is a few units past the line for your prescribed dose.

If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top. (Example Dose: 20 units Plunger is shown at 24 units) Step 9: Slowly push the Plunger up until the tip reaches the line for your prescribed dose. Check the syringe to make sure that you have the right dose.

(Example Dose: 20 units shown) Step 10: Pull the syringe out of the vial's Rubber Stopper. Giving your HUMULIN N injection: Inject your insulin exactly as your healthcare provider has shown you. Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.

Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Step 11: Choose your injection site.

HUMULIN N is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms. Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.

Step 12: Insert the needle into your skin. Step 13: Push down on the Plunger to inject your dose. The needle should stay in your skin for at least 5 seconds to make sure you have injected all of your insulin dose.

Step 14: Pull the needle out of your skin. If you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. Do not rub the area.

Do n… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 134 words ▾

PACKAGE CARTON – HUMULIN N Vial 10 mL 1ct NDC 0002-8315-01 100 units per mL (U-100) Humulin® N NPH (insulin isophane human) injectable suspension 10 mL multiple-dose vial Use only with a U-100 syringe For subcutaneous use only. U-100 www.lilly.com Lilly PACKAGE CARTON – HUMULIN N Vial 10 mL 1ct

PACKAGE LABEL – Humulin N KwikPen 3mL 5ct 5 x 3 mL prefilled pens NDC 0002-8805-59 HP-8805 Humulin ® N KwikPen ® NPH (insulin isophane human) injectable suspension For Single Patient Use Only Dispense in this sealed carton Read Insulin Delivery Device Instructions for Use For subcutaneous use only. prefilled insulin delivery device 100 units per mL (U-100) Needles not included This device is suitable for use with Becton, Dickinson and Company's insulin pen needles. Lilly PACKAGE LABEL – Humulin N KwikPen 3mL 5ct

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial00002-8315-01 66,953 Rx · $6,054,591
1 vial00002-8315-17 No Medicaid data
1 vial this page00002-8315-99 No Medicaid data
Drug total (last 4 qtrs): 66,953 Rx · 1,307,407 units · $6,054,591 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 N — 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 N. 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
$4.64M
Claims incl. refills
35.8K
Beneficiaries
25.4K
Spend / beneficiary
$182.87
Spend / claim
$129.73
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 Insulin human — the ingredient across all brands.

Top reported reactions

Blood Glucose Increased10,691
Blood Glucose Decreased3,484
Hypoglycaemia1,556
Nausea1,513
Visual Impairment1,502
Weight Decreased1,324
Dyspnoea1,304

Age at onset

Neonate110
Infant17
Child29
Adolescent23
Adult2,353
Elderly1,961

Reporter sex

41,198 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization13,162
Death2,932
Life-threatening1,529
Disabling1,371
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,305 0
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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eli Lilly and Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 vial (00002-8315-01), 1 vial (00002-8315-17). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Eli Lilly and Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as 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.
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.
← 00002-8235-05 · Eli 00002-8351-05 · 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.