Quick answers
- What is Amlodipine and olmesartan medoxomil used for?
- The FDA-approved label (Azor, Cosette Pharmaceuticals, Inc., July 12, 2023) says: “Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amlodipine and olmesartan medoxomil have a boxed warning?
- Yes. The FDA label for Azor has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Amlodipine and olmesartan medoxomil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amlodipine and olmesartan medoxomil been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started July 8, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Amlodipine and olmesartan medoxomil?
- 15 companies list prescription products of Amlodipine and olmesartan medoxomil in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Ascend Laboratories, LLC and Amneal Pharmaceuticals NY LLC.
What Amlodipine and olmesartan medoxomil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. …
— FDA label: Azor, Cosette Pharmaceuticals, Inc., effective July 12, 2023. Read the full label on DailyMed →
The FDA has 14 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: FETAL TOXICITY
. Read it on the full label →
14 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 54 in the FDA NDC Directory |
| Brand names | Azor |
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 |
|---|---|---|
| amlodipine besylate 10 mg · olmesartan medoxomil 20 mg tablet | Generic | $0.2719 per tablet |
| amlodipine besylate 10 mg · olmesartan medoxomil 20 mg tablet, film coated | Generic | $0.2719 per tablet |
| amlodipine besylate 10 mg · olmesartan medoxomil 40 mg tablet | Generic | $0.2982 per tablet |
| amlodipine besylate 10 mg · olmesartan medoxomil 40 mg tablet, film coated | Generic | $0.2982 per tablet |
| amlodipine besylate 10 mg · olmesartan medoxomil 40 mg tablet, film coated | Brand: Azor | $19.54 per tablet |
| amlodipine besylate 5 mg · olmesartan medoxomil 20 mg tablet | Generic | $0.2350 per tablet |
| amlodipine besylate 5 mg · olmesartan medoxomil 20 mg tablet, film coated | Generic | $0.2350 per tablet |
| amlodipine besylate 5 mg · olmesartan medoxomil 20 mg tablet, film coated | Brand: Azor | $15.32 per tablet |
| amlodipine besylate 5 mg · olmesartan medoxomil 40 mg tablet | Generic | $0.3362 per tablet |
| amlodipine besylate 5 mg · olmesartan medoxomil 40 mg tablet, film coated | Generic | $0.3362 per tablet |
| amlodipine besylate 5 mg · olmesartan medoxomil 40 mg tablet, film coated | Brand: Azor | $19.63 per tablet |
NADAC list of November 4, 2026; these prices took effect between July 1, 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.
- Camber Pharmaceuticals, Inc.4 products
- Ascend Laboratories, LLC4 products
- Amneal Pharmaceuticals NY LLC4 products
- Cosette Pharmaceuticals, Inc.4 products
- Micro Labs Limited4 products
- Aurobindo Pharma Limited4 products
- Ajanta Pharma USA Inc.4 products
- Alembic Pharmaceuticals Limited4 products
- ScieGen Pharmaceuticals, Inc.4 products
- Alembic Pharmaceuticals Inc.4 products
- AvKARE4 products
- Golden State Medical Supply, Inc.4 products
- Macleods Pharmaceuticals Limited4 products
- A-S Medication Solutions1 product
- Bryant Ranch Prepack1 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 |
|---|---|---|---|
| NDA022100 AZOR | Cosette | September 26, 2007 | 22, latest October 2, 2020 2020: Labeling · 2017: Labeling · 2016: Labeling |
Generic approvals (8)
- ANDA206884Macleods Pharms · October 26, 2016
- ANDA207216Ajanta Pharma Ltd · October 28, 2016
- ANDA206906Aurobindo Pharma · May 15, 2017
- ANDA207073Alembic · July 17, 2017
- ANDA209042Alkem Labs Ltd · August 14, 2017
- ANDA207435Micro Labs · November 2, 2017
- ANDA209010Sciegen Pharms · December 3, 2018
- ANDA209591Hetero Labs Ltd V · February 14, 2025
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.
-
July 8, 2026 · Class II · Ongoing · D-0712-2026
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500- — Ascend Laboratories, LLC
-
May 5, 2026 · Class II · Ongoing · D-0556-2026
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30. — Ascend Laboratories, LLC
-
July 21, 2025 · Class II · Ongoing · D-0576-2025
Failed Dissolution Specifications: low dissolution results
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30 — Ascend Laboratories, LLC
-
February 15, 2022 · Class II · Terminated · D-0632-2022
cGMP deviations
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pra — Macleods Pharma Usa Inc
-
March 15, 2021 · Class II · Terminated · D-0509-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal — Cardinal Health Inc.
-
November 30, 2018 · Class III · Terminated · D-0289-2019
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30 — Aurobindo Pharma USA 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azor, Cosette Pharmaceuticals, Inc., effective July 12, 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 →