Quick answers
- What is Penicillin v potassium used for?
- The FDA-approved label (Penicillin V Potassium, Remedyrepack Inc., September 3, 2026) says: “Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Penicillin v potassium have a boxed warning?
- No. None of the 55 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Penicillin v potassium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Penicillin v potassium been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Penicillin v potassium?
- 15 companies list prescription products of Penicillin v potassium in the FDA NDC Directory, including PD-Rx Pharmaceuticals, Inc., NuCare Pharmaceuticals, Inc. and A-S Medication Solutions.
What Penicillin v potassium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE …
— FDA label: Penicillin V Potassium, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
The FDA has 55 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 55 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Powder, for solution · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 73 in the FDA NDC Directory |
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 |
|---|---|---|
| penicillin v potassium 125 mg/5 mL powder, for solution | Generic | $0.0499–$0.0779 per mL 2 packages, lowest to highest |
| penicillin v potassium 250 mg tablet | Generic | $0.0596 per tablet |
| penicillin v potassium 250 mg tablet, film coated | Generic | $0.0596 per tablet |
| penicillin v potassium 250 mg/5 mL powder, for solution | Generic | $0.0475–$0.0611 per mL 2 packages, lowest to highest |
| penicillin v potassium 500 mg tablet | Generic | $0.0977 per tablet |
| penicillin v potassium 500 mg tablet, film coated | Generic | $0.0977 per tablet |
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.
- PD-Rx Pharmaceuticals, Inc.13 products
- NuCare Pharmaceuticals, Inc.13 products
- A-S Medication Solutions9 products
- Remedyrepack Inc.6 products
- Proficient Rx LP5 products
- Bryant Ranch Prepack5 products
- Teva Pharmaceuticals USA, Inc.4 products
- Chartwell RX, LLC4 products
- Preferred Pharmaceuticals Inc.3 products
- Aurobindo Pharma Limited2 products
- Rising Health, LLC2 products
- Redpharm Drug2 products
- NorthStar Rx LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- QPharma, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA060711Chartwell Rx · July 3, 1968
- ANDA060456Chartwell Rx · July 31, 1968
- ANDA065435Aurobindo Pharma · April 29, 2008
- ANDA090549Hikma Pharms · October 11, 2013
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 15, 2021 · Class II · Terminated · D-0576-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73 — Cardinal Health Inc.
-
November 28, 2017 · Class III · Terminated · D-0108-2018
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuti — Teva Pharmaceuticals USA
-
February 24, 2017 · Class III · Terminated · D-0652-2017
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99 — Citron Pharma Llc
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) | 834040, 834046, 834061, 834102 |
|---|---|
| SPL set ID of the quoted label | dd8a48b2-9ff1-49de-a53e-db4964c2384c |
| FDA labels (SPL) | 55 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | PENICILLIN V |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Penicillin V Potassium, Remedyrepack Inc., effective September 3, 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 →