Prescription drug · ANDA
Cefdinir NDC 82868-059
Cefdinir 300 mg/1 · Capsule · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82868-059-20 | 82868005920 | 20 CAPSULE in 1 BOTTLE, PLASTIC (82868-059-20)Marketed from Jun 25, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cefdinir
- Generic name (nonproprietary)
- cefdinir
- Active ingredients
- Cefdinir — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210220
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 82868-059_56326225-d131-7e42-e063-6294a90abd06SPL ID 56326225-d131-7e42-e063-6294a90abd06SPL set ID 1d0d50ba-8c2b-855c-e063-6394a90a5c7dRxCUI 200346UNII CI0FAO63WC
- Pharmacologic class
- Cephalosporin Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482868005920followed by a unit qualifier and the quantityPackage 82868-0059-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE To 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the desig…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210220
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7987 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7563 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8968 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6042 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6041 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-5101 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-543 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | American Health Packaging | 60687-699 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2401 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2503 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | DirectRx | 72189-308 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Redpharm Drug, Inc. | 67296-1448 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4169 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-576 |