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Prescription medicine · generic available

Cefdinir

Also listed by the FDA as: cefdinir · cefdinir monohydrate

Drug class: Cephalosporin Antibacterial

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
11Recalls (FDA reports)
22Companies
2006First FDA approval on file

Quick answers

What is Cefdinir used for?
The FDA-approved label (Cefdinir, NuCare Pharmaceuticals, Inc., September 1, 2026) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Cefdinir have a boxed warning?
No. None of the 66 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Cefdinir?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Cefdinir been recalled?
FDA enforcement reports list 11 recalls of products of this medicine; the newest started May 8, 2024 (Class II). A recall usually concerns specific lots, not every product.
Who makes Cefdinir?
22 companies list prescription products of Cefdinir in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., A-S Medication Solutions and Preferred Pharmaceuticals Inc..

What Cefdinir is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. …

— FDA label: Cefdinir, NuCare Pharmaceuticals, Inc., effective September 1, 2026. Read the full label on DailyMed →

The FDA has 66 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.

Pneumonia

Related medical specialties

Infectious Disease

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 66 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Powder, for suspension
RouteOral
Prescription products81 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.

NADAC per unit for Cefdinir, by strength and form
Strength and formGeneric or brandPharmacies pay
cefdinir 125 mg/5 mL
powder, for suspension		 Generic $0.1076–$0.1116 per mL
6 packages, lowest to highest
cefdinir 250 mg/5 mL
powder, for suspension		 Generic $0.1106–$0.1189 per mL
6 packages, lowest to highest
cefdinir 300 mg
capsule		 Generic $0.4454 per capsule
cefdinir monohydrate 125 mg/5 mL
powder, for suspension		 Generic $0.1076–$0.1116 per mL
2 packages, lowest to highest
cefdinir monohydrate 250 mg/5 mL
powder, for suspension		 Generic $0.1106–$0.1189 per mL
2 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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (9)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. May 8, 2024 · Class II · Terminated · D-0518-2024

    Defective container: lack of seal integrity.

    Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180- — Lupin Pharmaceuticals Inc.

  2. April 24, 2024 · Class II · Terminated · D-0497-2024

    Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

    Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man — Lupin Pharmaceuticals Inc.

  3. April 24, 2024 · Class II · Terminated · D-0496-2024

    Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

    Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man — Lupin Pharmaceuticals Inc.

  4. July 2, 2020 · Class II · Terminated · D-1406-2020

    Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

    Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20 — Lupin Pharmaceuticals Inc.

  5. November 1, 2019 · Class III · Terminated · D-0306-2020

    Presence of Foreign substance: identified as a dead ant.

    Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United — Lupin Pharmaceuticals Inc.

  6. November 1, 2019 · Class III · Terminated · D-0305-2020

    Presence of Foreign substance: identified as a dead ant.

    Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 6 — Lupin Pharmaceuticals Inc.

  7. May 23, 2019 · Class II · Terminated · D-1320-2019

    Complaint received of metal piece identified in the product bottle prior to the reconstitution.

    Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 — Lupin Pharmaceuticals Inc.

  8. January 2, 2019 · Class II · Terminated · D-0375-2019

    CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

    Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited M — Lupin Pharmaceuticals Inc.

  9. January 2, 2019 · Class II · Terminated · D-0376-2019

    CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

    Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited M — Lupin Pharmaceuticals Inc.

  10. March 27, 2018 · Class II · Terminated · D-0684-2018

    Superpotent Drug

    Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 — Lupin Pharmaceuticals Inc.

  11. February 26, 2013 · Class II · Terminated · D-247-2013

    Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.

    Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960. — Teva Pharmaceuticals 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

RxCUI (RxNorm)200346, 309054, 476576
SPL set ID of the quoted label5a72e445-b920-b97d-e063-6294a90af2ee
FDA labels (SPL)66
FDA applications9 ANDA
Active ingredients (FDA)CEFDINIR

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cefdinir, NuCare Pharmaceuticals, Inc., effective September 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers