Prescription medicine
Cefdinir First approved as Omnicef
Cefdinir (Omnicef) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.458 per cefdinir 300 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cefdinir FDA label on DailyMed (effective October 14, 2025, Lupin Pharmaceuticals, Inc.); the NDA 50739 record on Drugs@FDA; every cefdinir label on DailyMed.
Highlights of the record
FDA label of October 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Forms and strengths
- 300 mg
- 125 mg/5ml
- 250 mg/5ml
Capsule; powder for suspension.
On the market
- Earliest approval on file
- December 4, 1997 Omnicef, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 19, 2006; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 26 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.458 per capsule Cefdinir 300 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 11 since 2013 0 Class I among all firms' recalls; latest May 8, 2024
- FAERS reports
- 7,628 through July 30, 2026
What is cefdinir used for?
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. […]
Conditions named in the indications of cefdinir's FDA labels, with every medicine labeled for each:
From other cefdinir labelsBacterial infections: Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Cefdinir), Lupin Pharmaceuticals, Inc., effective October 14, 2025 (SPL set cb7366ce-1778-451f-aba5-65cf73c9b87a), via openFDA; the full label on DailyMed
Is there a generic for cefdinir (Omnicef)?
The FDA approved the first generic cefdinir on May 19, 2006. 12 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cefdinir from 26 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2006 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cefdinir (Omnicef)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.458 per Cefdinir 300 mg capsule, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cefdinir 300 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cefdinir 125 mg/5 mL suspension | Generic | $0.108 per mL | n/a | -5% |
| Cefdinir 250 mg/5 mL suspension | Generic | $0.114 per mL | n/a | -15% |
| Cefdinir 300 mg capsule | Generic | $0.458 per capsule | $13.74 | +0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cefdinir been recalled?
The FDA's Enforcement Report lists 11 recalls naming cefdinir since 2013: 0 Class I (the most serious), 9 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 8, 2024 | Class II | Lupin Pharmaceuticals Inc. | Defective container: lack of seal integrity. |
| April 24, 2024 | Class II | Lupin Pharmaceuticals Inc. | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. |
| July 2, 2020 | Class II | Lupin Pharmaceuticals Inc. | Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. |
| November 1, 2019 | Class III | Lupin Pharmaceuticals Inc. | Presence of Foreign substance: identified as a dead ant. |
| May 23, 2019 | Class II | Lupin Pharmaceuticals Inc. | Complaint received of metal piece identified in the product bottle prior to the reconstitution. |
| January 2, 2019 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. |
| March 27, 2018 | Class II | Lupin Pharmaceuticals Inc. | Superpotent Drug |
| February 26, 2013 | Class II | Teva Pharmaceuticals USA, Inc. | Defective Container: This recall is being carried out due to the potential for improperly sealed bottles. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cefdinir label say about other medicines?
The cefdinir label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings | SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. |
| Probenecid | drug interactions | As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak cefdinir plasma levels, and a 50% prolongation in the apparent elimination t 1/2 . |
Source: FDA drug label (Cefdinir), Lupin Pharmaceuticals, Inc., effective October 14, 2025 (SPL set cb7366ce-1778-451f-aba5-65cf73c9b87a), via openFDA; the full label on DailyMed
What do FAERS reports show for cefdinir?
The FDA Adverse Event Reporting System holds 7,628 reports that list cefdinir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 579 are coded as a death and 2,462 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cefdinir?
23 other medicines are given the same way (oral) and in the same FDA class as cefdinir or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Cefuroxime | Bacterial infections | 17 labelers | $0.280 per tablet 250 mg tablet | No current entry |
| Cefadroxil | Bacterial infections | 19 labelers | $0.269 per capsule 500 mg capsule | No current entry |
| Cefpodoxime | Bacterial infections | 11 labelers | $1.04 per tablet 100 mg tablet | No current entry |
| Cefprozil | Bacterial infections | 7 labelers | $0.925 per tablet 500 mg tablet | No current entry |
| Cefixime | Bacterial infections | 6 labelers | $10.03 per capsule 400 mg capsule | No current entry |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cefdinir compare with medicines for the same use?
15 side-by-side pages set cefdinir beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cefdinir
- 23 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefdinir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other