Quick answers
- What is Insulin human used for?
- The FDA-approved label (Afrezza, Mannkind Corporation, May 30, 2026) says: “AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Insulin human have a boxed warning?
- Yes. The FDA label for Afrezza has a boxed warning (“WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Insulin human?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Insulin human been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Insulin human?
- 3 companies list prescription products of Insulin human in the FDA NDC Directory, including Mannkind Corporation, Baxter Healthcare Corporation and Eli Lilly and Company.
What Insulin human is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. Limitations of Use …
— FDA label: Afrezza, Mannkind Corporation, effective May 30, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
. Read it on the full label →
1 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Powder, metered · Injection, solution |
|---|---|
| Route | Respiratory (inhalation) · Intravenous · Subcutaneous |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Afrezza, Myxredlin, Humulin R U-500 Kwikpen |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| insulin human 12 [arb'U] powder, metered | Brand: Afrezza | $15.59 per unit |
| insulin human 4 [arb'U] powder, metered | Brand: Afrezza | $5.21 per unit |
| insulin human 500 units/mL injection, solution | Brand: Humulin R U-500 KwikPen | $91.60 per mL |
| insulin human 8 [arb'U] powder, metered | Brand: Afrezza | $10.35 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mannkind Corporation3 products
- Baxter Healthcare Corporation1 product
- Eli Lilly and Company1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA018780 HUMULIN R, HUMULIN R KWIKPEN, HUMULIN R PEN | Lilly | October 28, 1982 | 101, latest June 27, 2022 2022: Labeling · 2019: Labeling · 2019: Labeling |
| BLA022472 AFREZZA | Mannkind | June 27, 2014 | 14, latest May 29, 2026 2026: Efficacy · 2026: Efficacy · 2023: Labeling |
| BLA208157 MYXREDLIN | Baxter Hlthcare Corp | June 20, 2019 | 2, latest March 7, 2025 2025: Labeling · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 6, 2026 · Class II · Ongoing · D-0806-2026
CGMP Deviations
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12. — Baxter Healthcare Corporation
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Afrezza, Mannkind Corporation, effective May 30, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →