Quick answers
- What is Oseltamivir phosphate used for?
- The FDA-approved label (Tamiflu, Genentech, Inc., December 15, 2025) says: “TAMIFLU is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. Prophylaxis of influenza A and B in patients 1 year and older. Limitations of Use: Not a substitute for annual influenza vaccination. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oseltamivir phosphate have a boxed warning?
- No. None of the 78 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Oseltamivir phosphate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oseltamivir phosphate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started February 13, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Oseltamivir phosphate?
- 37 companies list prescription products of Oseltamivir phosphate in the FDA NDC Directory, including Proficient Rx LP, A-S Medication Solutions and Sportpharm LLC.
What Oseltamivir phosphate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TAMIFLU is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. Prophylaxis of influenza A and B in patients 1 year and older. Limitations of Use: Not a substitute for annual influenza vaccination. …
— FDA label: Tamiflu, Genentech, Inc., effective December 15, 2025. Read the full label on DailyMed →
The FDA has 78 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 78 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Powder, for suspension · For suspension · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 127 in the FDA NDC Directory |
| Brand names | Tamiflu |
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 |
|---|---|---|
| oseltamivir phosphate 30 mg capsule | Generic | $0.6443 per capsule |
| oseltamivir phosphate 45 mg capsule | Generic | $0.8157 per capsule |
| oseltamivir phosphate 6 mg/mL for suspension | Generic | $0.1555 per mL |
| oseltamivir phosphate 6 mg/mL powder, for suspension | Generic | $0.1555 per mL |
| oseltamivir phosphate 6 mg/mL powder, for suspension | Brand: Tamiflu | $2.43 per mL |
| oseltamivir phosphate 6 mg/mL suspension | Generic | $0.1555 per mL |
| oseltamivir phosphate 75 mg capsule | Generic | $0.7981 per capsule |
| oseltamivir phosphate 75 mg capsule | Brand: Tamiflu | $14.52 per capsule |
NADAC list of November 4, 2026; these prices took effect between February 18, 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.
- Proficient Rx LP11 products
- A-S Medication Solutions7 products
- Sportpharm LLC6 products
- Preferred Pharmaceuticals Inc.6 products
- Asclemed USA, Inc.5 products
- Novadoz Pharmaceuticals LLC4 products
- Lannett Company, Inc.4 products
- Epic Pharma, LLC4 products
- Alembic Pharmaceuticals Limited4 products
- Alvogen Inc.4 products
- Alembic Pharmaceuticals Inc.4 products
- Strides Pharma Science Limited4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Exelan Pharmaceuticals Inc.4 products
- Lupin Pharmaceuticals, Inc.4 products
- Amneal Pharmaceuticals NY LLC4 products
- NuCare Pharmaceuticals, Inc.4 products
- Camber Pharmaceuticals, Inc.4 products
- Zydus Lifesciences Limited4 products
- Shandong New Time Pharmaceutical Co., Ltd.3 products
- Remedyrepack Inc.3 products
- Genentech, Inc.3 products
- AvKARE3 products
- Laurus Labs Limited3 products
- Amneal Pharmaceuticals LLC3 products
- Redpharm Drug3 products
- Zhejiang Poly Pharm. Co., Ltd.3 products
- Macleods Pharmaceuticals Limited3 products
- MSN Laboratories Private Limited1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Cipla USA Inc.1 product
- Ajanta Pharma USA Inc.1 product
- Aurobindo Pharma Limited1 product
- Leading Pharma, LLC1 product
- Oryza Pharmaceuticals Inc.1 product
- Slate Run Pharmaceuticals, LLC1 product
- HEC Pharm USA Inc.1 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 |
|---|---|---|---|
| NDA021087 TAMIFLU | Roche | October 27, 1999 | 63, latest August 2, 2019 2019: Efficacy · 2018: Labeling · 2018: Labeling |
| NDA021246 TAMIFLU | Roche | December 14, 2000 | 47, latest August 10, 2021 2021: Manufacturing (CMC) · 2019: Efficacy · 2018: Labeling |
Generic approvals (31)
- ANDA202595Natco · August 3, 2016
- ANDA208578Zydus Pharms · February 24, 2017
- ANDA209093Amneal Pharms · May 17, 2017
- ANDA207211Macleods Pharms · September 14, 2017
- ANDA209113Zydus Pharms · September 14, 2017
- ANDA208823Alvogen · October 31, 2017
- ANDA208348Lupin · January 9, 2018
- ANDA208347Lupin · February 20, 2018
- ANDA209438Hetero Labs Ltd III · February 23, 2018
- ANDA210186Amneal Pharms Ny · February 27, 2018
- ANDA209421Strides Pharma · June 8, 2018
- ANDA211125Teva Pharms USA · February 27, 2019
- ANDA211823Alembic · June 24, 2019
- ANDA212739Sunshine · March 4, 2020
- ANDA212544Msn · May 20, 2020
- ANDA212784Ajanta Pharma Ltd · May 27, 2020
- ANDA212858Invagen Pharms · August 30, 2021
- ANDA215208Epic Pharma LLC · October 1, 2021
- ANDA213594Sunshine · January 5, 2022
- ANDA211894Strides Pharma · January 13, 2022
- ANDA214949Leading · February 28, 2022
- ANDA209590Hetero Labs Ltd V · March 28, 2022
- ANDA215313Msn · May 2, 2022
- ANDA215538Epic Pharma LLC · February 14, 2023
- ANDA217467Invagen Pharms · October 3, 2023
- ANDA218009Zhejiang Poly Pharm · November 24, 2023
- ANDA218565Laurus · May 1, 2024
- ANDA218131Aurobindo Pharma Ltd · May 10, 2024
- ANDA217303Pharmobedient · July 2, 2024
- ANDA217274Shandong · July 9, 2025
- ANDA218307Alembic · June 25, 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.
-
February 13, 2024 · Class II · Terminated · D-0327-2024
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6 — Amneal Pharmaceuticals of New York, LLC
-
March 15, 2021 · Class II · Terminated · D-0423-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, N — Cardinal Health Inc.
-
January 21, 2021 · Class III · Terminated · D-0247-2021
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Ma — Lupin Pharmaceuticals 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) — Tamiflu, Genentech, Inc., effective December 15, 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 →