Quick answers
- What is Insulin aspart used for?
- The FDA-approved label (Novolog, A-S Medication Solutions, December 15, 2023) says: “NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Insulin aspart have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Insulin aspart?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Insulin aspart been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started March 22, 2021 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Insulin aspart?
- 8 companies list prescription products of Insulin aspart in the FDA NDC Directory, including Novo Nordisk, A-S Medication Solutions and Novo Nordisk Pharma, Inc..
What Insulin aspart is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
— FDA label: Novolog, A-S Medication Solutions, effective December 15, 2023. Read the full label on DailyMed →
The FDA has 16 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.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, suspension |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 35 in the FDA NDC Directory |
| Brand names | Novolog, Novolog Mix 70/30, Fiasp, Insulin Aspart Protamine and Insulin Aspart Mix 70/30, Garzulys, Kirsty, Merilog, .Insulin Aspart Protamine and Insulin Aspart |
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 aspart 100 units/mL injection, solution | Generic | $6.95–$8.96 per mL 3 packages, lowest to highest |
| insulin aspart 100 units/mL injection, solution | Brand: Fiasp | $6.92–$8.91 per mL 4 packages, lowest to highest |
| insulin aspart 100 units/mL injection, solution | Brand: Merilog | $6.82–$8.71 per mL 2 packages, lowest to highest |
| insulin aspart 100 units/mL injection, solution | Brand: Novolog | $6.93–$8.93 per mL 3 packages, lowest to highest |
| insulin aspart 100 units/mL injection, suspension | Generic | $6.95–$8.93 per mL 2 packages, lowest to highest |
| insulin aspart 100 units/mL injection, suspension | Brand: NovoLog Mix 70/30 | $6.92–$8.93 per mL 2 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and 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.
- Novo Nordisk10 products
- A-S Medication Solutions7 products
- Novo Nordisk Pharma, Inc.5 products
- Novo Nordisk Pharmaceutical Industries, LP4 products
- Remedyrepack Inc.3 products
- Meitheal Pharmaceuticals Inc.2 products
- Biocon Biologics Inc.2 products
- Sanofi-Aventis U.S. LLC2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA020986 NOVOLOG, NOVOLOG FLEXPEN, NOVOLOG FLEXTOUCH, NOVOLOG INNOLET, NOVOLOG PENFILL | Novo Nordisk Inc | June 7, 2000 | 52, latest February 28, 2023 2023: Labeling · 2021: Manufacturing (CMC) · 2021: Labeling |
| BLA021172 NOVOLOG MIX 70/30, NOVOLOG MIX 70/30 FLEXPEN, NOVOLOG MIX 70/30 PENFILL | Novo Nordisk Inc | November 1, 2001 | 33, latest February 28, 2023 2023: Labeling · 2021: Labeling · 2019: Labeling |
| BLA208751 FIASP, FIASP FLEXTOUCH, FIASP PENFILL | Novo | September 29, 2017 | 10, latest June 21, 2023 2023: Labeling · 2019: Efficacy · 2019: Efficacy |
| BLA761188 KIRSTY | Biocon Biologics Inc | July 15, 2025 | — |
| BLA761325 MERILOG, MERILOG SOLOSTAR | Sanofi-Aventis U.S. LLC | February 14, 2025 | — |
| BLA761497 GARZULYS | Emerge Bioscience Pte. Ltd. | July 24, 2026 | — |
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.
-
March 22, 2021 · Class I · Terminated · D-0613-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90 — Novo Nordisk Inc
-
March 22, 2021 · Class I · Terminated · D-0611-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, — Novo Nordisk Inc
-
March 22, 2021 · Class I · Terminated · D-0612-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91 — Novo Nordisk Inc
-
March 22, 2021 · Class I · Terminated · D-0615-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit) — Novo Nordisk Inc
-
March 22, 2021 · Class I · Terminated · D-0616-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90 — Novo Nordisk Inc
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
| RxCUI (RxNorm) | 311040, 351297, 351926, 847191, 977840, 977842, 1653196, 1653198, 1653202, 1653204 … (+10) |
|---|---|
| SPL set ID of the quoted label | 13891e5a-e57a-46e8-911c-2f680352b52b |
| FDA labels (SPL) | 16 |
| FDA applications | BLA020986, BLA021172, BLA208751, BLA761188, BLA761325, BLA761497 |
| Active ingredients (FDA) | INSULIN ASPART |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Novolog, A-S Medication Solutions, effective December 15, 2023; 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 →