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Lantus insulin glargine 100 [iU]/mL Injection, Solution, 10 mL — NDC 50090-0876-0 (Billing 50090-0876-00)

by A-S Medication Solutions · 10 mL in 1 VIAL, GLASS

This is a package of 10 mL of Lantus insulin glargine 100 [iU]/mL Injection, Solution from A-S Medication Solutions, marketed since Sep 2009 and currently FDA-listed. It is this product's only package size.

NDC 50090-0876-00
🏷️ FDA NDC (as labeled) 50090-0876-0 billing pads the package segment with a zero
Rx only 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 50090-0876-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50090 labeler · 0876 product · 0 package
Package marketed since
Nov 28, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
10 mL per package
Barcode (UPC-A, from the NDC)
3 5009008760 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-0876-0
Product NDC 50090-0876
11-digit billing NDC 50090087600
NCPDP billing unit ML — per mL (volume)
RxCUI 285018, 311041
UNII 2ZM8CX04RZ
Application # BLA021081
SPL Set ID ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99
Established class (EPC) Insulin Analog
Chemical class Insulin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-23
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance INSULIN GLARGINE
Biologic (Purple Book) 351(a)

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

GPI-14 27104003002020
GPI class Lantus
GCN Seq No 047780
GCN 13072
HICL code 022025
Ingredient (HICL) Insulin Glargine,Hum.rec.anlog
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4G
Therapeutic class — specific (HIC3) Insulins
AHFS code 68:20.08.00
AHFS class Insulins
FDB label name LANTUS 100 UNIT/ML VIAL
FDB brand name Lantus
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047780
  • GCN: 13072
  • GPI-14 (Medi-Span): 27104003002020
  • HICL (First Databank): 022025
  • AHFS class code: 68:20.08.00
  • RxCUI (RxNorm): 285018
Why two NDCs? The FDA registers this code as 50090-0876-0 — a 5-4-1 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 package segment → 50090-0876-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Insulin Analog class.

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

Clinical

Label name LANTUS 100 UNIT/ML VIAL Ingredient Insulin Glargine,Hum.rec.anlog
📗 Our plain-language guide HelloPharmacist
  • 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-act...
  • What exactly is insulin glargine and why did my doctor prescribe it instead of regular insulin?
  • 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 help...
  • Does it matter what time of day I take my injection?
📖 Read our full Insulin Glargine (rDNA origin) Injection guide →
2
Nutrient depletion considerations

Insulin Glargine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Insulin Glargine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 · Q2 2026 $6.17 $61.74 / 10 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 Marketing startMarketing endStatus
50090-0876-00 You're viewing this Main listing 10 mL in 1 VIAL, GLASS 2014-11-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lantus 100 [iU]/mL 00088-2220-33 sanofi-aventis 1 vial $6.152 — Availability likely —
BASAGLAR KwikPen 100 [iU]/mL 00002-7715-59 Eli 5 syringes $20.935 — Availability likely —
BASAGLAR Tempo Pen 100 [iU]/mL 00002-8214-05 Eli 5 syringes $20.955 — Discontinued —
Lantus 100 [iU]/mLthis 50090-0876-00 A-S 10 ml — — FDA listed —
Lantus Solostar 100 [iU]/mL 50090-1398-00 A-S 5 syringes — — FDA listed —
Lantus Solostar 100 [iU]/mL 50090-4068-00 A-S 5 syringes — — FDA listed —
Insulin Glargine Solostar 100 [iU]/mL 50090-6178-00 A-S 5 syringes — — Discontinued —
Lantus Solostar 100 [iU]/mL 00088-2219-00 sanofi-aventis 1 syringe — — 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

🏛️
2000
First FDA approval
Apr 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
2026
Biosimilars listed
1 FDA-licensed
🧬FDA-licensed biosimilars listed

1 interchangeable is FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Basaglarinsulin glargine Lantusinsulin glargine Semgleeinsulin glargine Toujeoinsulin glargine
Interchangeable 1
Rezvoglarinsulin glargine-aglr
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.

🧪 Avoiding an ingredient? See Insulin Glargine (rDNA origin) Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 20 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.
  • 2.7 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.
  • 20 ug / 1 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid 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.
  • 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.
  • 30 ug / 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.

7 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

LabelerA-S Medication Solutions
FDA applicationBLA021081 (BLA)
Labeler code50090
First marketedSep 2009
Product typeHuman Prescription Drug
Portfolio2,811 products on file

More NDCs from A-S Medication Solutions labeler code 50090

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 69 words ▾

1 INDICATIONS AND USAGE LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ( 2.1 , 2.2 , 2.3 , 2.4 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ( 2.1 ) Do not dilute or mix with any other insulin or solution.

( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to change to LANTUS from other insulins ( 2.3 , 2.4 ) Closely monitor glucose when switching to LANTUS and during initial weeks thereafter. ( 2.4 )

2.1Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4) ] Visually inspect LANTUS vials and SoloStar prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. Administer LANTUS subcutaneously into the abdominal area, thigh, or deltoid, and 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) ] . Do not administer intravenously or via an insulin pump.

Do not dilute or mix LANTUS with any other insulin or solution. The LANTUS SoloStar prefilled pen dials in 1-unit increments. Use LANTUS SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

2.2General Dosing Instructions Administer LANTUS subcutaneously once daily at any time of day but at the same time every day. Individualize and adjust the dosage of LANTUS based on the patient'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), during acute illness, or changes in renal or hepatic function.

Dosage adjustments should only be made under medical supervision with appropriate glucose monitoring [see Warnings and Precautions (5.2) ] . In patients with type 1 diabetes, LANTUS must be used concomitantly with short-acting insulin.

2.3Initiation of LANTUS Therapy Recommended Starting Dosage in Patients with Type 1 Diabetes The recommended starting dosage of LANTUS in patients with type 1 diabetes is approximately one-third of the total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of the daily insulin requirements. Recommended Starting Dosage in Patients with Type 2 Diabetes The recommended starting dosage of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily.

2.4Switching to LANTUS from Other Insulin Therapies Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to LANTUS from other insulin therapies [see Warnings and Precautions (5.3) ]. When switching from: Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily LANTUS (100 units/mL), the recommended starting LANTUS dosage is 80% of the TOUJEO dosage that is being discontinued. Once-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is the same as the dosage of NPH that is being discontinued.

Twice-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is 80% of the total NPH dosage that is being discontinued.

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) a clear and colorless solution available as: 10 mL multiple-dose vial 3 mL single-patient-use LANTUS SoloStar prefilled pen Injection: 100 units/mL (U-100) available as: 10 mL multiple-dose vial ( 3 ) 3 mL single-patient-use SoloStar prefilled pen ( 3 )

⛔ Contraindications 56 words ▾

4 CONTRAINDICATIONS LANTUS is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.3) ] In patients with hypersensitivity to insulin glargine or any of the excipients in LANTUS [see Warnings and Precautions (5.5) ] During episodes of hypoglycemia ( 4 ) Hypersensitivity to insulin glargine or any of the excipients in LANTUS ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share a LANTUS SoloStar prefilled pen, insulin syringe, or needle 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.

Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. ( 5.3 , 6.1 ) Hypoglycemia due to medication errors : Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.

( 5.4 , 6.3 ) Hypersensitivity reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue LANTUS. Monitor and treat if indicated.

( 5.5 , 6.1 ) 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 of TZD if heart failure occurs.

( 5.7 )

5.1Never Share a LANTUS SoloStar Prefilled Pen, Insulin Syringe, or Needle Between Patients LANTUS SoloStar prefilled pens must never be shared between patients, even if the needle is changed. Patients using LANTUS vials must never re-use or 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 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 oral and antidiabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including LANTUS. 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, using drugs that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7) ] , or who experience recurrent hypoglycemia. The long-acting effect of LANTUS may delay recovery from 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 LANTUS may vary in different patients or at different times in the same p… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: 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) ] Adverse reactions commonly associated with LANTUS include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The data in Table 1 reflect the exposure of 2,327 patients with type 1 diabetes to LANTUS or NPH in Studies A, B, C, and D [see Clinical Studies (14.2) ] . The type 1 diabetes population had the following characteristics: Mean age was 39 years.

Fifty-four percent were male, 97% were Caucasian, 22% were Black or African American and 33% were Hispanic. The mean BMI was 25.1 kg/m 2 . The data in Table 2 reflect the exposure of 1,563 patients with type 2 diabetes to LANTUS or NPH in Studies E, F, and G [see Clinical Studies (14.3) ] .

The type 2 diabetes population had the following characteristics: Mean age was 59 years. Fifty-eight percent were male, 87% were Caucasian, 8% were Black or African American and 9% were Hispanic. The mean BMI was 29.2 kg/m 2 .

The frequencies of adverse reactions during LANTUS clinical studies in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below (Tables 1, 2, 3, and 4). Table 1: Adverse Reactions Occurring ≥5% in Pooled Clinical Studies up to 28 Weeks Duration in Adults with Type 1 Diabetes LANTUS, % (n=1,257) NPH, % (n=1,070) Upper respiratory tract infection 22.4

23.1Infection Body system not specified 9.4

10.3Accidental injury 5.7

6.4Headache 5.5

4.7Table 2: Adverse Reactions Occurring ≥5% in Pooled Clinical Studies up to 1 Year Duration in Adults with Type 2 Diabetes LANTUS, % (n=849) NPH, % (n=714) Upper respiratory tract infection 11.4

13.3Infection Body system not specified 10.4

11.6Retinal vascular disorder 5.8

7.4Table 3: Adverse Reactions Occurring ≥10% in a 5-Year Study of Adults with Type 2 Diabetes LANTUS, % (n=514) NPH, % (n=503) Upper respiratory tract infection 29.0

33.6Edema peripheral 20.0

22.7Hypertension 19.6

18.9Influenza 18.7

19.5Sinusitis 18.5

17.9Cataract 18.1

15.9Bronchitis 15.2

14.1Arthralgia 14.2

16.1Pain in extremity 13.0

13.1Back pain 12.8

12.3Cough 12.1

7.4Urinary tract infection 10.7

10.1Diarrhea 10.7

10.3Depression 10.5

9.7Headache 10.3

9.3Table 4: Adverse Reactions Occurring ≥5% in a 28-Week Clinical Study in Pediatric Patients with Type 1 Diabetes LANTUS, % (n=174) NPH, % (n=175) Infection Body system not specified 13.8

17.7Upper respiratory tract infection 13.8

16.0Pharyngitis 7.5

8.6Rhinitis 5.2

5.1Severe Hypoglycemia Hypoglycemia was the most commonly observed adverse reaction in patients treated with LANTUS. Tables 5, 6, and 7 summarize the incidence of severe hypoglycemia in the LANTUS clinical studies. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL (≤56 mg/dL in the 5-year study and ≤36 mg/dL in the ORIGIN study) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.

Percentages of LANTUS-treated adult patients who experienced severe symptomatic hypoglycemia in the LANTUS clinical studies [see Clinical Studies (14) ] were comparable to percentages of NPH-treated patients for all treatment regimens… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 8 includes clinically significant drug interactions with LANTUS. Table 8: Clinically Significant Drug Interactions with LANTUS 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), sulfonamide antibiotics. GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors.

Intervention : Dosage reductions and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of LANTUS 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 : Dosage increases and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of LANTUS Drugs : Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Intervention : Dosage adjustment and increased frequency of glucose monitoring may be required when LANTUS is coadministered 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 LANTUS is coadministered 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 ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day.

Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10.

The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-fetal Risk Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, 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 Published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.

Animal Data Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis.

The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

8.2Lactation Risk Summary There are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production. Endogenous insulin is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LANTUS, and any potential adverse effects on the breastfed child from LANTUS or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of LANTUS to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of LANTUS for this indication is supported by evidence from an adequate and well-controlled study (Study D) in 174 LANTUS-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of LANTUS in adults with diabetes mellitus [see Clinical Pharmacology (12.3) , Clinical Studies (14.2) ]. In the pediatric clinical study, pedia… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day.

Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10.

The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-fetal Risk Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, 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 Published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.

Animal Data Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis.

The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

🧒 Pediatric Use 112 words ▾

8.4Pediatric Use The safety and effectiveness of LANTUS to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of LANTUS for this indication is supported by evidence from an adequate and well-controlled study (Study D) in 174 LANTUS-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of LANTUS in adults with diabetes mellitus [see Clinical Pharmacology (12.3) , Clinical Studies (14.2) ]. In the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes [see Adverse Reactions (6.1) ] .

🧓 Geriatric Use 107 words ▾

8.5Geriatric Use Of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes who were treated with LANTUS, 15% (n=316) were ≥65 years of age and 2% (n=42) were ≥75 years of age. No overall differences in safety or effectiveness of LANTUS have been observed between patients 65 years of age and older and younger adult patients. Nevertheless, caution should be exercised when LANTUS is administered to geriatric patients.

In geriatric patients with diabetes, the initial dosing, dosage increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in geriatric patients.

🆘 Overdosage 92 words ▾

10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3 , 5.6) ] . Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Lowering the insulin dosage, and adjustments in meal patterns or exercise may be needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with glucagon for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous LANTUS is approximately the same as that for human insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after subcutaneous injection of LANTUS or NPH insulin. The median time between subcutaneous injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to >24 hours) (24 hours was the end of the observation period) for LANTUS. * Determined as amount of glucose infused to maintain constant plasma glucose levels Figure 1: Glucose-Lowering Effect Over 24 Hours in Patients with Type 1 Diabetes The duration of action after abdominal, deltoid, or thigh subcutaneous administration of LANTUS was similar.

The time course of action of insulins, including LANTUS, may vary between patients and within the same patient. Figure 1

12.3Pharmacokinetics Absorption After subcutaneous injection of LANTUS in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin. Elimination Metabolism A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des-30 B -Thr-insulin).

Unchanged drug and these degradation products are also present in the circulation. Specific Populations Age, Race, Body Mass Index, and Gender Effect of age, race, body mass index (BMI), and gender on the pharmacokinetics of insulin glargine has not been evaluated. However, in controlled clinical studies in adults (n=3,890) and a controlled clinical study in pediatric patients (n=349), subgroup analyses based on age, race, BMI, and gender did not show differences in safety and efficacy between LANTUS and NPH insulin [see Clinical Studies (14) ] .

🧬 Mechanism of Action 50 words ▾

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

📦 How Supplied / Storage and Handling 15 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-0876 NDC: 50090-0876-0 10 mL in a VIAL, GLASS

📋 Description 156 words ▾

11 DESCRIPTION Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da.

LANTUS (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial or a 3 mL single-patient use prefilled pen (LANTUS Solostar). Prefilled Pen (LANTUS Solostar) and Vial: Each mL contains 100 units of insulin glargine and the inactive ingredients: glycerol 85% (20 mg), m-cresol (2.7 mg), zinc (30 mcg), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg).

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). There are separate Instructions for Use for the Vial and LANTUS SoloStar Pen. Never Share a LANTUS SoloStar Prefilled Pen or Insulin Syringe Between Patients Advise patients that they must never share a LANTUS SoloStar pen with another person, even if the needle is changed.

Advise patients using LANTUS vials not to re-use or share needles or insulin syringes with another person. Sharing carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1) ] . Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin.

Inform patients of the symptoms of hypoglycemia (e.g., impaired ability to concentrate and react). This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. 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) ] . Hypoglycemia Due to Medications Errors Instruct patients to always check the insulin label before each injection to reduce the risk of a medication error [see Warnings and Precautions (5.4) ] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with LANTUS.

Inform patients about the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5) ].

🧬 Pharmacokinetics 182 words ▾

12.3Pharmacokinetics Absorption After subcutaneous injection of LANTUS in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin. Elimination Metabolism A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des-30 B -Thr-insulin).

Unchanged drug and these degradation products are also present in the circulation. Specific Populations Age, Race, Body Mass Index, and Gender Effect of age, race, body mass index (BMI), and gender on the pharmacokinetics of insulin glargine has not been evaluated. However, in controlled clinical studies in adults (n=3,890) and a controlled clinical study in pediatric patients (n=349), subgroup analyses based on age, race, BMI, and gender did not show differences in safety and efficacy between LANTUS and NPH insulin [see Clinical Studies (14) ] .

🧬 Pharmacodynamics 162 words ▾

12.2Pharmacodynamics In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous LANTUS is approximately the same as that for human insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after subcutaneous injection of LANTUS or NPH insulin. The median time between subcutaneous injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to >24 hours) (24 hours was the end of the observation period) for LANTUS. * Determined as amount of glucose infused to maintain constant plasma glucose levels Figure 1: Glucose-Lowering Effect Over 24 Hours in Patients with Type 1 Diabetes The duration of action after abdominal, deltoid, or thigh subcutaneous administration of LANTUS was similar.

The time course of action of insulins, including LANTUS, may vary between patients and within the same patient. Figure 1

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Overview of Clinical Studies The safety and effectiveness of LANTUS given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of 2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus (see Tables 9–11). In general, the reduction in glycated hemoglobin (HbA1c) with LANTUS was similar to that with NPH insulin.

14.2Clinical Studies in Adult and Pediatric Patients with Type 1 Diabetes Adult Patients with Type 1 Diabetes In two clinical studies (Studies A and B), adult patients with type 1 diabetes (Study A, n=585, Study B n=534) were randomized to 28 weeks of basal-bolus treatment with LANTUS or NPH insulin. Regular human insulin was administered before each meal. LANTUS was administered at bedtime.

NPH insulin was administered either as once daily at bedtime or in the morning and at bedtime when used twice daily. In Study A, the average age was 39 years. The majority of patients were White (99%) and 56% were male.

The mean BMI was approximately 24.9 kg/m 2 . The mean duration of diabetes was 16 years. In Study B, the average age was 39 years.

The majority of patients were White (95%) and 51% were male. The mean BMI was approximately 25.8 kg/m 2 . The mean duration of diabetes was 17 years.

In another clinical study (Study C), patients with type 1 diabetes (n=619) were randomized to 16 weeks of basal-bolus treatment with LANTUS or NPH insulin. Insulin lispro was used before each meal. LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily.

The average age was 39 years. The majority of patients were White (97%) and 51% were male. The mean BMI was approximately 25.6 kg/m 2 .

The mean duration of diabetes was 19 years. In these 3 adult studies, LANTUS and NPH insulin had similar effects on HbA1c (Table 9) with a similar overall rate of severe symptomatic hypoglycemia [see Adverse Reactions (6.1) ] . Table 9: Type 1 Diabetes Mellitus – Adults Study A Study B Study C Treatment duration 28 weeks 28 weeks 16 weeks Treatment in combination with Regular insulin Regular insulin Insulin lispro LANTUS NPH LANTUS NPH LANTUS NPH Number of subjects treated 292 293 264 270 310 309 HbA1c Baseline HbA1c 8.0 8.0 7.7 7.7 7.6

7.7Adjusted mean change at study end +0.2 +0.1 -0.2 -0.2 -0.1 -0.1 Treatment Difference (95% CI) +0.1 (0.0; +0.2) +0.1 (-0.1; +0.2) 0.0 (-0.1; +0.1) Basal insulin dose Baseline mean 21 23 29 29 28 28 Mean change from baseline -2 0 -4 +2 -5 +1 Total insulin dose Baseline mean 48 52 50 51 50 50 Mean change from baseline -1 0 0 +4 -3 0 Fasting blood glucose (mg/dL) Baseline mean 167 166 166 175 175 173 Adj. mean change from baseline -21 -16 -20 -17 -29 -12 Body weight (kg) Baseline mean 73.2 74.8 75.5 75.0 74.8

75.6Mean change from baseline 0.1 -0.0 0.7 1.0 0.1

0.5Pediatric Patients with Type 1 Diabetes In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily. The average age was 11.7 years.

The majority of patients were White (97%) and 52% were male. The mean BMI was approximately 18.9 kg/m 2 . The mean duration of diabetes was 5 years.

Similar effects on HbA1c (Table 10) were observed in both treatment groups [see Adverse Reactions (6.1) ] . Table 10: Type 1 Diabetes Mellitus – Pediatric Patients Study D Treatment duration 28 weeks Treatment in combination with Regular insulin LANTUS + Regular insulin NPH + Regular insulin Number of subjects treated 174 175 HbA1c Baseline mean 8.5

8.8Change from baseline (adjusted mean) +0.3 +0.3 Difference from NPH (adjusted mean) 0.0 (95% CI ) (-0.2; +0.3) Basal insulin d… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 207 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day) on a mg/kg basis. Histiocytomas were found at injection sites in male rats and mice in acid vehicle containing groups and are considered a response to chronic tissue irritation and inflammation in rodents.

These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters). In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dose of 0.2 units/kg/day (0.007 mg/kg/day) maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed.

Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 204 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day) on a mg/kg basis. Histiocytomas were found at injection sites in male rats and mice in acid vehicle containing groups and are considered a response to chronic tissue irritation and inflammation in rodents.

These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters). In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dose of 0.2 units/kg/day (0.007 mg/kg/day) maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed.

Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION LANTUS ® (LAN-tus) (insulin glargine) injection, for subcutaneous use VIAL:100 Units/mL (U-100) Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. What is LANTUS?

LANTUS is a long-acting man-made-insulin used to control high blood sugar in adults and children with diabetes mellitus. LANTUS is not for use to treat diabetic ketoacidosis. Who should not use LANTUS?

Do not use LANTUS if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin glargine or any of the ingredients in LANTUS. See the end of this Patient Information leaflet for a complete list of ingredients in LANTUS. What should I tell my healthcare provider before using LANTUS?

Before using LANTUS, tell your healthcare provider about all your medical conditions including if you: have liver or kidney problems. take other medicines, especially ones called TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with LANTUS. are pregnant, planning to become pregnant, or are breastfeeding. It is not known if LANTUS may harm your unborn baby or breastfeeding baby.

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

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

Know the amount of LANTUS you use. Do not change the amount of LANTUS you use unless your healthcare provider tells you to. Check your insulin label each time you give your injection to make sure you are using the correct insulin.

Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of LANTUS.

Using a new needle for each injection lowers your risk of getting an infection. You may take LANTUS at any time during the day but you must take it at the same time every day. Only use LANTUS that is clear and colorless.

If your LANTUS is cloudy or slightly colored, return it to your pharmacy for a replacement. LANTUS is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). Do not use LANTUS in an insulin pump or inject LANTUS into your vein (intravenously).

Change (rotate) injection sites within the area you chose 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. Do not mix LANTUS with any other type of insulin or liquid medicine. Check your blood sugar levels.

Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels. Keep LANTUS and all medicines out of the reach of children. Your dose of LANTUS may need to change because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of the medicines you take.

What should I avoid while using LANTUS? While using LANTUS do not: drive or operate heavy machinery, until you know how LANTUS affects you. drink alcohol or use over-the-counter medicines that contain alcohol. What are the possible side effects of LANTUS and other insulins?

LANTUS may cause serious side effects that can lead to death, including: low blood su… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE LANTUS ® (LAN-tus) (insulin glargine) injection, for subcutaneous use VIAL: 100 Units/mL (U-100) These Instructions for Use contain information on how to inject LANTUS using the vial. Read these Instructions for Use before you start taking LANTUS and each time you get a new LANTUS 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 LANTUS 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 LANTUS 10 mL 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. Preparing to Inject LANTUS: Wash your hands with soap and water or clean your hands with alcohol.

Check the LANTUS 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. Check the LANTUS in the vial to make sure it is clear and colorless.

Do not use LANTUS if it is colored or cloudy, or if you see particles in the solution. Do not use LANTUS after the expiration date stamped on the label or 28 days after you first use it. Always use a syringe that is marked for U-100 insulin.

If you use a syringe other than a U-100 insulin syringe, you may get the wrong dose of LANTUS. Always use a new syringe and a new needle for each injection to help prevent infections and prevent blocked needles. Step 1: If you are using a new LANTUS vial, remove the protective cap.

Do not remove the stopper. Step 2: Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of LANTUS before use.

Step 3: Draw air into the syringe equal to your LANTUS dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial. Step 4: Leave the syringe in the vial and turn both upside down.

Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the LANTUS solution. With your free hand, pull the plunger to withdraw the correct dose into the syringe.

Step 5: Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose.

Step 6: Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

Injecting LANTUS Inject your LANTUS (with a syringe) exactly as your healthcare provider has shown you. LANTUS is injected once daily at any time of the day but at the same time every day Step 7: Choose your injection site: LANTUS is injected under the skin (subcutaneously) of your upper arms, thighs, or stomach area (abdomen). Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in the 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. Wipe the skin with an alcohol swab to clean the injection site.

Let the injection site dry before you inject your dose. Step 8: Pinch the skin. Insert the needle under the skin in the way your healthcare provider showed you.

Release the skin. Slowly push in the plunger of the syringe all the way, making sure you have injected all the LANTUS. Leave the needle in the skin for about 10 seconds.

Step 9: Pull the needle straight out of your skin. Gently press the injection site for several seconds. Do not rub the area.

Do not recap the used needle. Recapp… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

insulin glargine Label Image

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

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

Medicare Part D (outpatient prescription) spending for Lantus — 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 Lantus. 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
$28.08M
Claims incl. refills
234.1K
Beneficiaries
141.2K
Spend / beneficiary
$198.79
Spend / claim
$119.93
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 Lantus (this brand).

Top reported reactions

Blood Glucose Increased21,717
Nausea8,009
Blood Glucose Decreased6,656
Hypoglycaemia6,434
Diarrhoea5,516
Fatigue5,336
Vomiting5,105

Age at onset

Neonate207
Infant36
Child302
Adolescent282
Adult16,795
Elderly14,594

Reporter sex

148,836 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization52,737
Death11,578
Life-threatening6,446
Disabling3,915
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,527 4,961
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

Finished prescription 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 — Not published for this NDC No photo available yet for this listing.
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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 50090-0858-00 · A-S 50090-0878-00 · A-S →
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.