Quick answers
- What is Dexamethasone used for?
- The FDA-approved label (Maxidex, Harrow Eye, LLC, May 5, 2025) says: “Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dexamethasone have a boxed warning?
- No. None of the 158 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dexamethasone?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 27, 2026). Ask your pharmacist about alternatives.
- Has Dexamethasone been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started February 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dexamethasone?
- 57 companies list prescription products of Dexamethasone in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Bryant Ranch Prepack and Medical Purchasing Solutions, LLC.
What Dexamethasone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation …
— FDA label: Maxidex, Harrow Eye, LLC, effective May 5, 2025. Read the full label on DailyMed →
The FDA has 158 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.
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 158 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, solution · Injection · Elixir · Solution, concentrate · Injection, emulsion · Solution · Implant · Insert · For suspension |
|---|---|
| Route | Oral · Intramuscular · Intravenous · Intra-articular · Intralesional · Soft tissue |
| Prescription products | 242 in the FDA NDC Directory |
| Brand names | Taperdex 6-Day, Hemady, Taperdex 12-Day, Ozurdex, Dextenza, Maxidex |
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 |
|---|---|---|
| dexamethasone 0.5 mg tablet | Generic | $0.0708 per tablet |
| dexamethasone 0.5 mg/0.5 mg tablet | Generic | $0.0708 per tablet |
| dexamethasone 0.5 mg/5 mL elixir | Generic | $0.1042 per mL |
| dexamethasone 0.5 mg/5 mL solution | Generic | $0.0296–$0.1705 per mL 2 packages, lowest to highest |
| dexamethasone 0.75 mg tablet | Generic | $0.0914 per tablet |
| dexamethasone 0.75 mg/0.75 mg tablet | Generic | $0.0914 per tablet |
| dexamethasone 1 mg tablet | Generic | $0.1477 per tablet |
| dexamethasone 1 mg/mL for suspension | Brand: Maxidex | $13.18 per mL |
| dexamethasone 1 mg/mL solution, concentrate | Generic | $0.7478 per mL |
| dexamethasone 1.5 mg tablet | Generic | $0.1808 per tablet |
| dexamethasone 2 mg tablet | Generic | $0.2602 per tablet |
| dexamethasone 4 mg tablet | Generic | $0.1989 per tablet |
| dexamethasone 6 mg tablet | Generic | $0.3895 per tablet |
| dexamethasone sodium phosphate 1 mg/mL solution/ drops | Generic | $8.31 per mL |
| dexamethasone sodium phosphate 10 mg/mL injection | Generic | $1.24–$1.26 per mL 4 packages, lowest to highest |
| dexamethasone sodium phosphate 10 mg/mL injection, solution | Generic | $0.5104–$1.26 per mL 8 packages, lowest to highest |
| dexamethasone sodium phosphate 4 mg/mL injection | Generic | $0.2014–$0.6700 per mL 3 packages, lowest to highest |
| dexamethasone sodium phosphate 4 mg/mL injection, solution | Generic | $0.2381–$0.7010 per mL 10 packages, lowest to highest |
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.
- Hikma Pharmaceuticals USA Inc.19 products
- Bryant Ranch Prepack13 products
- Medical Purchasing Solutions, LLC13 products
- Sportpharm LLC11 products
- Proficient Rx LP9 products
- Asclemed USA, Inc.9 products
- Fresenius Kabi USA, LLC9 products
- Direct_Rx7 products
- Viona Pharmaceuticals Inc7 products
- A-S Medication Solutions7 products
- Apotex Corp.7 products
- Zydus Lifesciences Limited7 products
- ANI Pharmaceuticals, Inc.7 products
- Advagen Pharma Ltd7 products
- HF Acquisition Co LLC, DBA HealthFirst7 products
- Mylan Institutional LLC7 products
- NorthStar Rx LLC6 products
- Preferred Pharmaceuticals Inc.6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Remedyrepack Inc.6 products
- Cardinal Health 107, LLC5 products
- Somerset Therapeutics, LLC5 products
- Eugia US LLC5 products
- Amneal Pharmaceuticals LLC4 products
- American Health Packaging3 products
- NuCare Pharmaceuticals, Inc.3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- Major Pharmaceuticals3 products
- Bionpharma Inc.3 products
- Doc Rx3 products
- Amneal Pharmaceuticals NY LLC3 products
- Gland Pharma Limited3 products
- Henry Schein, Inc.3 products
- Larken Laboratories, Inc.2 products
- Alvogen Inc.2 products
- Pangea Pharmaceuticals, LLC2 products
- Civica, Inc.2 products
- Sagent Pharmaceuticals2 products
- ProPharma Distribution2 products
- RedPharm Drug, Inc.1 product
- Northwind Health Company, LLC1 product
- Advanced Rx of Tennessee, LLC1 product
- Edenbridge Pharmaceuticals LLC.1 product
- Prasco Laboratories1 product
- Allergan, Inc.1 product
- Kanchan Healthcare Inc1 product
- Golden State Medical Supply, Inc.1 product
- Chartwell RX, LLC1 product
- Kesin Pharma Corporation1 product
- Marlex Pharmaceuticals, Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- Ocular Therapeutix, Inc.1 product
- Harrow Eye, LLC1 product
- Armas Pharmaceuticals1 product
- Phlow Corporation1 product
- Bausch & Lomb Incorporated1 product
- Micro Labs Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA013422 MAXIDEX | Harrow Eye | June 20, 1962 | 32, latest December 10, 2021 2021: Labeling · 2021: Labeling · 2017: Labeling |
| NDA022315 OZURDEX | Abbvie | June 17, 2009 | 12, latest March 11, 2026 2026: Labeling · 2022: Labeling · 2020: Labeling |
| NDA208742 DEXTENZA | Ocular Therapeutix | November 30, 2018 | 4, latest April 7, 2025 2025: Efficacy · 2021: Efficacy · 2020: Labeling |
| NDA211379 HEMADY | Dexcel | October 3, 2019 | 2, latest June 5, 2024 2024: Labeling · 2021: Labeling |
Generic approvals (47)
- ANDA080399Prasco · October 20, 1971
- ANDA084282Hikma · July 15, 1975
- ANDA084754Pharmazone · September 21, 1976
- ANDA084916Fresenius Kabi USA · September 6, 1977
- ANDA084612Hikma · July 19, 1978
- ANDA087702Hikma · September 7, 1982
- ANDA088149Pangea · April 28, 1983
- ANDA088237Key Therap · April 28, 1983
- ANDA088248Hikma · September 1, 1983
- ANDA088252Hikma · September 1, 1983
- ANDA088316Hikma · September 15, 1983
- ANDA088481Alvogen · December 15, 1983
- ANDA040069Bausch and Lomb Inc · July 26, 1996
- ANDA040491Fresenius Kabi USA · April 11, 2003
- ANDA040572Fresenius Kabi USA · April 22, 2005
- ANDA040802Mylan Labs Ltd · August 29, 2008
- ANDA040803Mylan Labs Ltd · August 29, 2008
- ANDA091188Chartwell Molecular · May 11, 2011
- ANDA090891Rising · July 12, 2011
- ANDA203129Fresenius Kabi USA · September 30, 2015
- ANDA206781Eugia Pharma · December 1, 2015
- ANDA201270Pharmobedient · July 17, 2017
- ANDA207442Somerset Theraps LLC · April 19, 2018
- ANDA207521Somerset · June 8, 2018
- ANDA209192Fresenius Kabi USA · July 6, 2018
- ANDA208689Amneal · August 22, 2018
- ANDA208690Amneal · August 22, 2018
- ANDA211036Somerset Theraps LLC · May 10, 2019
- ANDA210967Eugia Pharma · June 7, 2019
- ANDA210966Eugia Pharma · June 5, 2020
- ANDA215654Gland · August 4, 2021
- ANDA215106Amneal · October 14, 2021
- ANDA215604Novitium Pharma · August 8, 2022
- ANDA216295Amneal · September 8, 2022
- ANDA217001Bionpharma · April 19, 2023
- ANDA217538Bionpharma · April 26, 2023
- ANDA217696Novitium Pharma · May 9, 2023
- ANDA217695Apotex · August 23, 2023
- ANDA216282Zydus Lifesciences · February 7, 2024
- ANDA216283Zydus Lifesciences · February 7, 2024
Showing the 40 earliest of 47.
Shortage status
Current shortage · updated October 27, 2026 · first posted February 8, 2019
| Product | Dexamethasone Sodium Phosphate Preservative Free, Injection, 10 mg/1 mL (NDC 70069-021-25) |
|---|---|
| Availability | Available |
| Company | Somerset Therapeutics, LLC |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
February 4, 2026 · Class II · Ongoing · D-0398-2026
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 7006 — SOMERSET THERAPEUTICS LLC
-
May 23, 2024 · Class II · Ongoing · D-0555-2024
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150 — Eugia US LLC
-
December 20, 2018 · Class II · Completed · D-0387-2019
GMP Deviations: A silicone particulate was noted in Ozurdex.
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07 — Allergan, PLC.
-
November 6, 2017 · Class III · Terminated · D-0093-2018
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA. — West-Ward Pharmaceuticals Corp.
-
November 6, 2017 · Class III · Terminated · D-0094-2018
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 U — West-Ward Pharmaceuticals Corp.
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) — Maxidex, Harrow Eye, LLC, effective May 5, 2025; 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 →