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Insulin Glargine (rDNA origin) Injection

Insulin glargine is a long-acting insulin analog used to improve blood sugar control in adults and children with type 1 diabetes, and in adults with type 2 diabetes.

Brand names BasaglarLantusToujeoSemgleeRezvoglar +6 more
Drug class Insulin Analog
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Insulin Glargine (rDNA origin) Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Insulin glargine is a long-acting basal (background) insulin for type 1 diabetes and adult type 2 diabetes that helps muscle and fat cells pull in glucose and tells the liver to make less; one of the most widely used insulins, it has been on the U.S. market for over a decade and is made by several companies. Most people tolerate it well, and the things they notice are some weight gain and occasional redness or itching where they inject. The one thing to watch for is low blood sugar (hypoglycemia), which can strike suddenly and turn dangerous, so check your glucose regularly and keep glucose tablets within reach.

Clinical pearls

  • Never switch glargine brands, such as Lantus to Toujeo, without your prescriber, because the doses are not always equal.
  • Never mix glargine in the same syringe with your mealtime insulin, even to save an injection; it needs its own shot.
  • Check the label before every injection and never share your pen, even with a new needle, since it can spread infections.
  • Beta-blockers can hide the racing heart of a low, so check your glucose whenever you feel shaky, sweaty or confused.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2000
Companies listing it with the FDA3
FDA label last updatedDec 11, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Insulin Glargine (rDNA origin) Injection, written from its FDA label.

What Insulin Glargine (rDNA origin) Injection is used for

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Insulin glargine is a long-acting insulin analog used to help manage blood sugar levels in people with diabetes. Supported uses include:

  • Improving blood sugar control in adults and pediatric patients (age 6 and older) with type 1 diabetes mellitus
  • Improving blood sugar control in adults with type 2 diabetes mellitus
  • Safety and effectiveness in children under 6 with type 1 diabetes, and in children with type 2 diabetes, have not been established
  • Insulin glargine is not recommended for treating diabetic ketoacidosis in any of its forms

How Insulin Glargine (rDNA origin) Injection works

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Insulin glargine works like your body's natural insulin — it lowers blood sugar by helping your skeletal muscle and fat tissue absorb glucose, while at the same time telling the liver to produce less glucose on its own. It also prevents fat breakdown (lipolysis) and protein breakdown (proteolysis), and helps the body build protein. Because it is a long-acting formula, it releases slowly and evenly after a subcutaneous injection, providing steady background insulin coverage.

After injection, insulin glargine is broken down in the body into two active metabolites (M1 and M2) that have activity similar to natural human insulin.

Insulin Glargine (rDNA origin) Injection dosage

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Insulin glargine is injected once daily under the skin (subcutaneously) at the same time each day. It can be injected into the abdomen, thigh, or upper arm. Rotate the injection site with each dose to protect the skin.

  • Dose is individualized based on diabetes type, blood sugar monitoring results, and your glucose control goals — follow your prescriber's guidance closely
  • Do not mix or dilute insulin glargine with any other insulin or solution
  • When starting or switching insulins, check your blood sugar more frequently, especially in the first few weeks
  • If you miss a dose or need to adjust due to changes in meals, activity, or illness, contact your healthcare provider

Dosing details from the FDA-approved label

From the Insulin Glargine (rDNA origin) Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Insulin-naive patients with type 1 diabetes (starting dose)
    • Approximately one-third to one-half of the total daily insulin dose
    • The remainder of the total daily insulin dose should be given as a short-acting insulin and divided between each daily meal
    • As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose
    • Maximum glucose lowering effect may take five days to fully manifest; monitor glucose daily when initiating
  • Insulin-naive patients with type 2 diabetes (starting dose)
    • 0.2 units per kilogram of body weight once daily
  • Patients on once-daily long or intermediate-acting insulin (switching)
    • Start Insulin Glargine, U-300 at the same unit dose as the once-daily long-acting insulin dose
    • For patients controlled on LANTUS (insulin glargine, 100 units/mL), expect that a higher daily dose of Insulin Glargine, U-300 will be needed to maintain the same level of glycemic control
  • Patients on twice-daily long or intermediate-acting insulin (switching)
    • Start Insulin Glargine, U-300 at 80% of the total daily NPH or insulin detemir twice-daily dosage
    • Monitor glucose frequently in the first weeks of therapy
  • General dosing and titration
    • Inject subcutaneously once a day at the same time of day
    • Titrate the dose no more frequently than every 3 to 4 days
    • Maximum: SoloStar pen delivers up to 80 units in a single injection; Max SoloStar pen delivers up to 160 units in a single injection
    • Dosage adjustments may be needed with changes in physical activity, meal patterns, renal or hepatic function or during acute illness
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day. ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes ( 2.3 ) and how to switch to Insulin Glargine, U-300 from other insulins ( 2.4 ) Closely monitor glucose when switching to Insulin Glargine, U-300 and during initial weeks thereafter. ( 2.4 ) 2.1 Important Administration Instructions Always check insulin labels before administration. This product is TOUJEO (insulin glargine). [see Warnings and Precautions (5.4) ] . Visually inspect the Insulin Glargine, U-300 solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles. Inject Insulin Glargine, U-300 subcutaneously into the abdominal area, thigh, or deltoid. 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) , Adverse Reactions (6) ] . Use Insulin Glargine, U-300 with caution in patients with visual impairment who may rely on audible clicks to dial their dose. Do not administer Insulin Glargine, U-300 intravenously or in an insulin pump. Do not dilute or mix Insulin Glargine, U-300 with any other insulin products or solutions. Never transfer Insulin Glargine, U-300 from the cartridges of the Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar prefilled pen into a syringe for administration [see Warnings and Precautions (5.4) ] . 2.2 General Dosing Instructions Insulin Glargine, U-300 is available in 2 single-patient-use prefilled pens: The Insulin Glargine, U-300 SoloStar prefilled pen contains 450 units of insulin glargine. It delivers doses in 1-unit increments and can deliver up to 80 units in a single injection.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Insulin Glargine (rDNA origin) Injection side effects

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The most common side effects of insulin glargine include:

Common side effects

  • Low blood sugar (hypoglycemia) — the most common side effect
  • Allergic reactions, including redness or itching at the injection site
  • Skin changes at the injection site (lipodystrophy — dimpling or thickening)
  • Swelling (edema)
  • Weight gain
  • Rash or itching (pruritus)

When to get medical help

  • Get emergency help if you have signs of severe low blood sugar: confusion, seizures, loss of consciousness, or inability to swallow
  • Call your doctor if you notice signs of a serious allergic reaction: hives, difficulty breathing, swelling of the face or throat (anaphylaxis)
  • Call your doctor if you experience muscle cramps, weakness, or irregular heartbeat — these can be signs of low potassium (hypokalemia)
  • Seek care if you develop signs of heart failure: shortness of breath, rapid weight gain, or swelling in your legs — especially if you also take a thiazolidinedione (TZD) diabetes pill
  • Tell your doctor right away if your blood sugar stays too high or too low after switching insulin products or changing your injection site

Severe allergic reactions (anaphylaxis) and dangerously low blood sugar are rare but serious — seek emergency care immediately if they occur.

Insulin Glargine (rDNA origin) Injection warnings and precautions

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  • Hypoglycemia (low blood sugar) is the most common and most dangerous risk — it can cause seizures, loss of consciousness, and death. Know the symptoms and always have a fast-acting sugar source available.
  • Never share insulin glargine pens between patients, even with a new needle — doing so risks transmitting bloodborne diseases.
  • Always check your insulin label before injecting — accidental mix-ups with other insulins, especially rapid-acting ones, have been reported and can cause serious harm.
  • Low potassium (hypokalemia) can occur — this can cause dangerous heart rhythms. Patients on potassium-lowering medications need monitoring.
  • Serious allergic reactions, including anaphylaxis, can occur — stop using insulin glargine and get emergency care if this happens.
  • Heart failure risk increases when insulin is used with thiazolidinedione (TZD) diabetes medications — watch for fluid retention and swelling.
  • Changes to your insulin regimen (brand, type, injection site) should always be made with medical supervision and increased blood sugar monitoring.

Insulin Glargine (rDNA origin) Injection interactions

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Several medications and substances can change how insulin glargine works in your body — raising or lowering blood sugar in ways that may require dose adjustments:

  • May increase low blood sugar risk: other diabetes medications, ACE inhibitors, ARBs, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, pramlintide, salicylates, octreotide, sulfonamide antibiotics
  • May reduce insulin's blood sugar-lowering effect: corticosteroids, diuretics, estrogens, thyroid hormones, atypical antipsychotics (e.g., olanzapine, clozapine), glucagon, isoniazid, niacin, oral contraceptives, protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine)
  • May have unpredictable effects (raise or lower blood sugar): alcohol, beta-blockers, clonidine, lithium salts; pentamidine may first cause low blood sugar then rebound high blood sugar
  • May mask symptoms of low blood sugar: beta-blockers, clonidine, guanethidine, reserpine — these make it harder to notice a dropping blood sugar level
  • TZD diabetes pills (e.g., pioglitazone) combined with insulin can cause fluid retention and heart failure

Interactions listed in the FDA-approved label

From the Insulin Glargine (rDNA origin) Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics: May increase the risk of hypoglycemia. Dose reductions and increased frequency of glucose monitoring may be required.
  • Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), thyroid hormones: May decrease the blood glucose lowering effect. Dose increases and increased frequency of glucose monitoring may be required.
  • Alcohol, beta-blockers, clonidine, lithium salts: May increase or decrease the blood glucose lowering effect. Dose adjustment and increased frequency of glucose monitoring may be required.
  • Pentamidine: May cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required.
  • Beta-blockers, clonidine, guanethidine, reserpine: May blunt signs and symptoms of hypoglycemia. Increased frequency of glucose monitoring may be required.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with BASAGLAR Table 6: Clinically Significant Drug Interactions with BASAGLAR 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 analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when BASAGLAR is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of BASAGLAR 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 increases and increased frequency of glucose monitoring may be required when BASAGLAR is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of BASAGLAR 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 BASAGLAR 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 BASAGLAR is co-administered with these drugs.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿242 supplements and herbs with documented Insulin Glargine (rDNA origin) Injection interactions, ranked by severity Check Insulin Glargine (rDNA origin) Injection against a supplement or herb →

Before taking Insulin Glargine (rDNA origin) Injection

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  • Do not use insulin glargine during an active low blood sugar episode (hypoglycemia)
  • Do not use if you have had a serious allergic reaction to insulin glargine or any of its ingredients
  • Kidney problems: insulin requirements may change; more frequent monitoring is needed
  • Liver problems: insulin requirements may change; more frequent monitoring is needed
  • Older adults: start at conservative doses; low blood sugar may be harder to recognize and more dangerous in elderly patients
  • Children under 6: safety and effectiveness have not been established
  • Pregnancy: poorly controlled diabetes during pregnancy raises risks for both mother and baby; published data have not found a clear link between insulin glargine and birth defects, but discuss with your doctor
  • Breastfeeding: limited data are available on insulin glargine in breast milk; discuss risks and benefits with your healthcare provider
  • Visual impairment: use caution with prefilled pens that rely on audible clicks to dial the dose

Insulin Glargine (rDNA origin) Injection overdose

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Taking more insulin than your body needs — whether from a dosing error or mismatch with food intake or activity — can cause severe, prolonged, and potentially life-threatening low blood sugar (hypoglycemia) and low potassium levels (hypokalemia). Mild low blood sugar can often be treated with oral glucose (juice, glucose tablets); severe episodes involving loss of consciousness or seizures require emergency treatment with glucagon or intravenous glucose. Monitor carefully after apparent recovery, as low blood sugar can return.

What Insulin Glargine (rDNA origin) Injection does in the body

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Insulin glargine U-300 begins lowering blood sugar gradually, with the onset of action developing over about 6 hours after a subcutaneous injection. On a unit-for-unit basis, Insulin Glargine U-300 has a lower peak glucose-lowering effect and a different distribution profile compared to Lantus (insulin glargine 100 units/mL). With daily dosing, the full blood sugar-lowering effect builds over approximately 5 days as the drug reaches steady-state levels in the body.

How your body processes Insulin Glargine (rDNA origin) Injection

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After a subcutaneous injection of Insulin Glargine U-300, insulin levels in the blood peak at around 12 to 16 hours depending on the dose, then gradually decline over the following hours. Steady-state concentrations are typically reached after at least 5 days of once-daily dosing. In the body, insulin glargine is broken down into two active metabolites (M1 and M2) that work similarly to natural human insulin. There is some variability in how much insulin enters the bloodstream from one injection to the next, which is why consistent injection technique and site rotation are important.

How to store Insulin Glargine (rDNA origin) Injection

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Dispense in the original sealed carton with the enclosed Instructions for Use. stored in the freezer and should not be allowed to freeze. are summarized in the following table: Insulin Glargine, U-300 Not in-use (unopened) Refrigerated 36°F–46°F (2°C–8°C) In-use (opened) To preve…

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

242

Supplements & herbs that interact with Insulin Glargine (rDNA origin) Injection

242 supplements and herbal products have documented interactions with Insulin Glargine (rDNA origin) Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 211
  • Minor · 29
CHELATION THERAPY PRODUCTS Major SIBERIAN COCKLEBUR Major ACAI Moderate AFRICAN WILD POTATO Moderate AGARICUS MUSHROOM Moderate AGMATINE Moderate AGRIMONY Moderate ALFALFA Moderate +234 more
Every supplement checked against Insulin Glargine (rDNA origin) Injection — ranked by severity The full interaction hub: 2 major · 211 moderate · 29 minor · every one linked to its full report. Check Insulin Glargine (rDNA origin) Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

2

Nutrient depletion considerations

Insulin Glargine (rDNA origin) Injection has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insignificant Depletion MAGNESIUM Insignificant Depletion
See the full Insulin Glargine (rDNA origin) Injection nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Insulin Glargine (rDNA origin) Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Insulin Glargine (rDNA origin) Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is insulin glargine and why did my doctor prescribe it instead of regular insulin?

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Insulin glargine is a long-acting insulin — it's designed to provide a slow, steady background level of insulin over the course of the day, rather than a quick spike like short-acting insulins do. Your doctor likely prescribed it to give your blood sugar a stable baseline between meals and overnight. Many people with type 1 or type 2 diabetes use a long-acting insulin like this as their 'foundation,' sometimes alongside a faster insulin taken at mealtimes.

Does it matter what time of day I take my injection?

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You can take insulin glargine at any time of day that works for your routine — morning, evening, whenever. The key is to take it at the same time every single day. Consistency helps keep your blood sugar levels steady and predictable. If you miss a dose or aren't sure what to do, contact your prescriber rather than doubling up.

What does low blood sugar feel like, and what should I do if it happens?

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Low blood sugar (hypoglycemia) can feel like shakiness, sweating, a racing heart, dizziness, confusion, or sudden hunger. It can happen quickly. If you catch it early and can swallow safely, treat it with a fast-acting sugar — like glucose tablets, juice, or regular soda. If someone loses consciousness or can't swallow, they need emergency help right away. Always keep a fast-acting sugar source on hand, and make sure people close to you know what to do in an emergency.

Can I mix insulin glargine in the same syringe as my mealtime insulin to save myself an injection?

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No — you should never mix insulin glargine with any other insulin or solution. Mixing can change how it works and affect your blood sugar control in unpredictable ways. Also, if you use a prefilled pen like the SoloStar, never transfer the insulin into a syringe — the pens are designed to be used as-is. Take your injections separately.

Are there any medications I should tell my doctor about before starting insulin glargine?

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Yes — a lot of common medications can affect your blood sugar when you're on insulin. Some raise the risk of low blood sugar (like certain blood pressure meds, antidepressants, or cholesterol-lowering drugs), while others can reduce how well insulin works (like steroids or certain antipsychotics). Even beta-blockers for heart or blood pressure can mask the early warning signs of low blood sugar, making it harder to notice. Always give your doctor and pharmacist a full list of everything you take, including over-the-counter products.

Is insulin glargine safe to use during pregnancy?

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Controlling your blood sugar during pregnancy is really important — for both you and your baby. Published studies haven't found a clear link between insulin glargine and birth defects or pregnancy complications, but data are limited. Poorly controlled diabetes during pregnancy does raise real risks. Talk openly with your doctor about the best insulin plan for you while pregnant or if you're planning to become pregnant — your insulin needs often change during this time.

Is Insulin Glargine (rDNA origin) Injection available over the counter?

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No. Insulin Glargine (rDNA origin) Injection is a prescription medicine: every Insulin Glargine (rDNA origin) Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Insulin Glargine (rDNA origin) Injection first available?

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The earliest FDA record we hold for Insulin Glargine (rDNA origin) Injection is from 2000: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Insulin Glargine (rDNA origin) Injection was first used.

Who makes Insulin Glargine (rDNA origin) Injection?

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3 companies currently list Insulin Glargine (rDNA origin) Injection products in the FDA's NDC Directory, including Sanofi-Aventis U.S. LLC, A-S Medication Solutions, Eli Lilly and Company. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Insulin Glargine (rDNA origin) Injection on HelloPharmacist

📊Insulin Glargine (rDNA origin) Injection supplement interactions242 checked — ranked by severity 🌿Drug & Supplement CheckerInsulin Glargine (rDNA origin) Injection vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Insulin Glargine (rDNA origin) Injection NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Insulin Glargine (rDNA origin) Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Insulin Glargine (rDNA origin) Injection forms and strengths (how it comes)

Insulin Glargine (rDNA origin) Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Under the skin
Brands Basaglar Insulin glargine U-300 Max Lantus Lantus Solostar Toujeo TOUJEO Max
How this form is used
What it may be used for
  • Used to improve blood sugar control in adults and children with type 1 diabetes mellitus
  • Used to improve blood sugar control in adults with type 2 diabetes mellitus
  • Insulin glargine U-300 Max is a prefilled pen designed for patients requiring at least 20 units per day, delivering doses in 2-unit increments up to 160 units per injection
  • Not recommended for treating diabetic ketoacidosis in any formulation
Important instructions
  • Inject subcutaneously into the abdomen, thigh, or upper arm once daily at the same time each day; rotate injection sites with every dose
  • Insulin Glargine U-300 Max SoloStar and Insulin Glargine U-300 SoloStar prefilled pens must never be transferred into a syringe for administration
  • Never mix or dilute any insulin glargine product with other insulins or solutions in the same syringe or pen
  • Always check the label on your pen before each injection to avoid accidental mix-ups between insulin products
Available strengths 5 strengths
100 [IU]/mL INSULIN GLARGINE 100 U/mL 300 U/mL 300 [IU]/mL INSULIN GLARGINE 300 U/mL
32 FDA-listed product records ⓘ

Insulin Glargine (rDNA origin) Injection on the U.S. market: products, makers and brands

How Insulin Glargine (rDNA origin) Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3 companies list 12 Insulin Glargine (rDNA origin) Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2000. Brand names on the directory include Basaglar, Lantus, Toujeo and 8 more; the rest are generics.

1
Dose forms ⓘ
3
Labelers (makers, repackagers, distributors)
8
Brand names
12
FDA-listed product records ⓘ
2000
Earliest FDA record ⓘ
Sanofi-Aventis U.S. LLC50%
A-S Medication Solutions42%
Eli Lilly and Company8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Insulin Glargine (rDNA origin) Injection is used (Medicaid data)

A general measure of how commonly Insulin Glargine (rDNA origin) Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Insulin Glargine (rDNA origin) Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,731,821
Medicaid prescriptions filled (Q1–Q4 2025)
$571.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Insulin Glargine (rDNA origin) Injection prescribed? Of the 1,601 medications we measure, Insulin Glargine (rDNA origin) Injection ranks #56 by Medicaid prescriptions — more than 97% of them.

Where Insulin Glargine (rDNA origin) Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #56 of 1,601
#51 Methadone 4,056,849 Rx #52 Guanfacine 4,043,576 Rx #53 Lisdexamfetamine 3,941,773 Rx #54 Cephalexin 3,933,834 Rx #55 Rosuvastatin 3,856,155 Rx #56 Insulin Glargine (rDNA... 3,731,821 Rx #57 Clonazepam 3,602,972 Rx #58 Fluconazole 3,462,620 Rx #59 Polyethylene Glycol 33... 3,441,581 Rx #60 Doxycycline 3,416,939 Rx #61 Risperidone 3,411,596 Rx

Utilization by Insulin Glargine (rDNA origin) Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 3 mL / 100 units/mL pen injector is the most-dispensed Insulin Glargine (rDNA origin) Injection product — about 76% of these Medicaid prescriptions.

3 ML insulin glargine 100 UNT/ML Pen Injector Most dispensed

2,832,694 Medicaid prescriptions (Q1–Q4 2025) 76% of Insulin Glargine (rDNA origin) Injection prescriptions shown $392M gross reimbursement (before rebates) ≈ $138 per prescription (gross)

Summed across the 3 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 847230

insulin glargine 100 UNT/ML Injectable Solution

390,939 Medicaid prescriptions (Q1–Q4 2025) 10% of Insulin Glargine (rDNA origin) Injection prescriptions shown $48.7M gross reimbursement (before rebates) ≈ $125 per prescription (gross)

Summed across the 3 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311041

3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector

305,985 Medicaid prescriptions (Q1–Q4 2025) 8% of Insulin Glargine (rDNA origin) Injection prescriptions shown $39.1M gross reimbursement (before rebates) ≈ $128 per prescription (gross)

Summed across the 4 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2563971

3 ML insulin glargine 300 UNT/ML Pen Injector

57,613 Medicaid prescriptions (Q1–Q4 2025) 2% of Insulin Glargine (rDNA origin) Injection prescriptions shown $49.5M gross reimbursement (before rebates) ≈ $859 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2002419

insulin glargine-yfgn 100 UNT/ML Injectable Solution

55,581 Medicaid prescriptions (Q1–Q4 2025) 1% of Insulin Glargine (rDNA origin) Injection prescriptions shown $6.9M gross reimbursement (before rebates) ≈ $123 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2563976

1.5 ML insulin glargine 300 UNT/ML Pen Injector

54,873 Medicaid prescriptions (Q1–Q4 2025) 1% of Insulin Glargine (rDNA origin) Injection prescriptions shown $30.9M gross reimbursement (before rebates) ≈ $564 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1604539

3 ML insulin glargine-aglr 100 UNT/ML Pen Injector

32,532 Medicaid prescriptions (Q1–Q4 2025) <1% of Insulin Glargine (rDNA origin) Injection prescriptions shown $3.4M gross reimbursement (before rebates) ≈ $104 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2589008

Sensor 3 ML insulin glargine 100 UNT/ML Pen Injector

1,604 Medicaid prescriptions (Q1–Q4 2025) <1% of Insulin Glargine (rDNA origin) Injection prescriptions shown $624,611 gross reimbursement (before rebates) ≈ $389 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2268064

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Insulin Glargine (rDNA origin) Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 18 of 56 listed Insulin Glargine (rDNA origin) Injection NDCs with Medicaid activity.

Compare Insulin Glargine (rDNA origin) Injection products

A representative set of FDA-listed product records for Insulin Glargine (rDNA origin) Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
100 [IU]/mL Subcutaneous A-S Medication Solutions × 3 listings BLA View NDC →
INSULIN GLARGINE 300 U/mL Subcutaneous A-S Medication Solutions × 2 listings BLA View NDC →
100 [IU]/mL Subcutaneous Eli Lilly and Company BLA View NDC →
100 [IU]/mL Subcutaneous sanofi-aventis U.S. LLC × 2 listings BLA View NDC →
300 [IU]/mL Subcutaneous Sanofi-Aventis U.S. LLC × 2 listings BLA View NDC →
INSULIN GLARGINE 300 U/mL Subcutaneous Sanofi-Aventis U.S. LLC × 2 listings BLA View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Insulin Glargine (rDNA origin) Injection NDCs →

Insulin Glargine (rDNA origin) Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Insulin Glargine recalls since July 2021.

✅No Insulin Glargine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Insulin Glargine (rDNA origin) Injection RxCUI 274783 2 dose forms · 9 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 378864 In current FDA listings
    Clinical drug / strength (SCD) yfgn 100 UNT/ML RxCUI 2563976 100 UNT/ML RxCUI 311041

Look up RxCUI 274783 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Insulin Glargine (rDNA origin) Injection costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Injection, Solution · Subcutaneous 100 [IU]/mL $20.94 per mL NDC details & price history
Injection, Solution · Subcutaneous 300 U/mL $91.30 per mL NDC details & price history
Injection, Solution · Subcutaneous INSULIN GLARGINE 300 U/mL $91.30 per mL NDC details & price history
Injection, Solution · Subcutaneous 300 [IU]/mL $27.01 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Insulin Glargine (rDNA origin) Injection brand names

Insulin Glargine (rDNA origin) Injection is sold under 11 brand names in the FDA directory — Basaglar, Lantus, Toujeo, Semglee and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Basaglar Lantus Toujeo Semglee Rezvoglar Langlara Lantus Solostar TOUJEO Max BASAGLAR KwikPen Insulin glargine U-300 Max BASAGLAR Tempo Pen

Who makes Insulin Glargine (rDNA origin) Injection: manufacturers and labelers

3 companies list Insulin Glargine (rDNA origin) Injection products with the FDA. By number of product records, the largest are Sanofi-Aventis U.S. LLC, A-S Medication Solutions, Eli Lilly and Company. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Sanofi-Aventis U.S. LLC 6 A-S Medication Solutions 5 Eli Lilly and Company 1

Insulin Glargine (rDNA origin) Injection drug class (RxNorm)

Insulin Glargine (rDNA origin) Injection belongs to the Insulin Analog class.

Pharmacologic class Insulin Analog
Drug family (ATC) Insulins and analogues for injection, long-acting

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Insulin Glargine (rDNA origin) Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 11, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Insulin Glargine (rDNA origin) Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Insulin Glargine (rDNA origin) Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
Finished products in the current FDA directory
12
Companies listing them (makers, repackagers, distributors)
3
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Eli Lilly and Company
Linked label effective
Dec 11, 2025
Composite sections available
23
Linked SPL Set ID
0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae
Linked SPL Document ID
3c2283e6-2844-44d2-a447-579b07e77c27
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Eli Lilly and Company is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →