Public record

Insulin glargine: the public record

6 tables from US federal sources. Latest data date: Nov 11, 2026.

Each table is computed from the named federal dataset as of its data date; the method is under each one.

Label

FDA label facts for insulin glargine

The FDA label read for insulin glargine (LANGLARA, application BLA761412) was last revised on 2026-10-15. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for insulin glargine: the figures
MeasureValueNote
Label revision date2026-10-15
Label readLANGLARABLA761412, brand-name application
Boxed warningNo
Indications section opensquoted in note"LANGLARA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus."
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

How this was calculated

Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.

Scope: One label: the newest prescription label for single-ingredient insulin glargine from an original manufacturer

Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.

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Approvals

FDA approval history for insulin glargine

The earliest FDA approval on file for a insulin glargine product is 2015-12-16. Drugs@FDA lists 2 applications for it and 8 approved supplements, the most recent on 2021-07-20.

FDA approval history for insulin glargine: the figures
MeasureValueNote
Earliest FDA approval on file2015-12-16
Applications with an approval on file2
New drug applications (NDA)0
Generic applications (ANDA)0
Biologics applications (BLA)2
Approved supplements8label, manufacturing and efficacy changes
Most recent supplement approval2021-07-20
Sponsoring companies2

Source: FDA, Drugs@FDA, data as of Nov 11, 2026

How this was calculated

Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.

Scope: Applications with a single-ingredient insulin glargine product in Drugs@FDA, all sponsors and strengths

Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.

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Medicaid

Medicaid prescriptions for insulin glargine by state

State Medicaid programmes paid for 3,779,678 insulin glargine prescriptions in 2025, with $562.6M reimbursed before rebates. California reported the most (521,735), followed by New York (330,025) and Pennsylvania (192,581); 52 states and territories reported any.

Medicaid prescriptions for insulin glargine by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 20253,779,678
Total reimbursed before rebates, 2025$562.6M
States and territories reporting52with at least one count CMS did not suppress
California521,735 prescriptions$121.8M reimbursed
New York330,025 prescriptions$48.8M reimbursed
Pennsylvania192,581 prescriptions$28.1M reimbursed
Ohio189,884 prescriptions$31.6M reimbursed
Illinois158,555 prescriptions$25.4M reimbursed

Source: CMS, Medicaid State Drug Utilization Data 2025, data as of 2025

How this was calculated

Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.

Scope: All single-ingredient insulin glargine products in the FDA NDC Directory, fee-for-service and managed care, 2025

Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.

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Pharmacy cost

Pharmacy acquisition cost (NADAC) for insulin glargine

Retail pharmacies paid an average of $2.90 per mL for INSULIN GLARGINE-YFGN U100 PEN as of 2026-11-11, compared with $5.92 twelve months earlier (-51.1%). This is a pharmacy purchase cost, not a patient price.

Pharmacy acquisition cost (NADAC) for insulin glargine: the figures
MeasureValueNote
INSULIN GLARGINE-YFGN U100 PEN$2.90 per mL12 months earlier $5.92 (-51.1%)
INSULIN GLARGINE MAX SOLO U300$26.96 per mL12 months earlier $36.68 (-26.5%)
INSULIN GLARGINE SOLOSTAR U300$26.99 per mL12 months earlier $36.70 (-26.5%)
INSULIN GLARGINE-YFGN U100 VL$6.09 per mL12 months earlier $6.11 (-0.4%)

Source: CMS, National Average Drug Acquisition Cost (NADAC), data as of Nov 11, 2026

How this was calculated

Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.

Scope: Generic versions of insulin glargine in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12

NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.

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Recalls

FDA drug recalls naming insulin glargine

FDA enforcement reports list 3 drug recall entries naming insulin glargine from 2022 to 2022-08-03. 3 of them are for compounded or other unlisted products and 0 for products FDA lists under a label. The most common stated reason was labelling or packaging error (3 of 3).

FDA drug recalls naming insulin glargine: the figures
MeasureValueNote
Recall entries on record3
For products FDA lists under an approved or registered label0
For compounded or other unlisted products3matched by the name in the product description
Class I (most serious)3
Class II0
Class III0
Most recent recall reported2022-08-03
Most common stated reasonlabelling or packaging error3 of 3 entries

Source: FDA, Enforcement Reports (drug recalls) via openFDA, data as of Nov 10, 2026

How this was calculated

Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.

Scope: Recalls of single-ingredient insulin glargine products, plus compounded or unlisted products whose description names it

Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.

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Clinical studies

Registered clinical studies of insulin glargine

ClinicalTrials.gov lists 727 registered studies that name insulin glargine as an intervention as of 2026-11-11. Of these, 12 are recruiting, 587 are completed and 240 are phase 3 studies.

Registered clinical studies of insulin glargine: the figures
MeasureValue
Registered studies727
Recruiting now12
Not yet recruiting4
Completed587
Terminated, withdrawn or suspended62
Phase 3 (including phase 2/3)240
Phase 2 (including phase 1/2)34
Phase 181

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

How this was calculated

Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.

Scope: Studies whose intervention field matches insulin glargine, any condition, any country, all statuses

A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.

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Articles on Insulin glargine