Public record
Insulin glargine: the public record
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.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-10-15 | |
| Label read | LANGLARA | BLA761412, brand-name application |
| Boxed warning | No | |
| Indications section opens | quoted in note | "LANGLARA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus." |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 2015-12-16 | |
| Applications with an approval on file | 2 | |
| New drug applications (NDA) | 0 | |
| Generic applications (ANDA) | 0 | |
| Biologics applications (BLA) | 2 | |
| Approved supplements | 8 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2021-07-20 | |
| Sponsoring companies | 2 |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 3,779,678 | |
| Total reimbursed before rebates, 2025 | $562.6M | |
| States and territories reporting | 52 | with at least one count CMS did not suppress |
| California | 521,735 prescriptions | $121.8M reimbursed |
| New York | 330,025 prescriptions | $48.8M reimbursed |
| Pennsylvania | 192,581 prescriptions | $28.1M reimbursed |
| Ohio | 189,884 prescriptions | $31.6M reimbursed |
| Illinois | 158,555 prescriptions | $25.4M reimbursed |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| INSULIN GLARGINE-YFGN U100 PEN | $2.90 per mL | 12 months earlier $5.92 (-51.1%) |
| INSULIN GLARGINE MAX SOLO U300 | $26.96 per mL | 12 months earlier $36.68 (-26.5%) |
| INSULIN GLARGINE SOLOSTAR U300 | $26.99 per mL | 12 months earlier $36.70 (-26.5%) |
| INSULIN GLARGINE-YFGN U100 VL | $6.09 per mL | 12 months earlier $6.11 (-0.4%) |
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.
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.
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).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 3 | |
| For products FDA lists under an approved or registered label | 0 | |
| For compounded or other unlisted products | 3 | matched by the name in the product description |
| Class I (most serious) | 3 | |
| Class II | 0 | |
| Class III | 0 | |
| Most recent recall reported | 2022-08-03 | |
| Most common stated reason | labelling or packaging error | 3 of 3 entries |
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.
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.
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.
| Measure | Value |
|---|---|
| Registered studies | 727 |
| Recruiting now | 12 |
| Not yet recruiting | 4 |
| Completed | 587 |
| Terminated, withdrawn or suspended | 62 |
| Phase 3 (including phase 2/3) | 240 |
| Phase 2 (including phase 1/2) | 34 |
| Phase 1 | 81 |
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.
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.
Articles on Insulin glargine
- Insulin Glargine (Lantus) Safety Signals and FDA Actions
- Lantus (Insulin Glargine) FDA Label Updates: 2020 to 2026
- How to Safely Stop Lantus (Insulin Glargine): A Clinician-Guided Discontinuation Protocol
- Lantus Missed-Dose Protocol: What to Do When You Skip Insulin Glargine
- Lantus Pharmacokinetics: How Insulin Glargine Is Absorbed, Distributed, Metabolized, and Eliminated
- How to Inject Lantus: Step-by-Step Technique