Prescription drug · ANDA
cefdinir NDC 67877-547
Cefdinir 125 mg/5mL · Powder, For suspension · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-547-88 | 67877054788 | 100 mL in 1 BOTTLE (67877-547-88)Marketed from Feb 20, 2021 | |
| 67877-547-98 | 67877054798 | 60 mL in 1 BOTTLE (67877-547-98)Marketed from Feb 20, 2021 |
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 — 125 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210534
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 67877-547_662007e2-462e-4513-b5b0-efd5dcdc2421SPL ID 662007e2-462e-4513-b5b0-efd5dcdc2421SPL set ID efb5a975-75ec-46e1-ba84-f68d0b9bf36fRxCUI 309054, 476576UNII 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
N467877054788followed by a unit qualifier and the quantityPackage 67877-0547-88. 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 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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated mi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210534
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 125 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8115 |
| cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-7929 |
| cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Ascend Laboratories, LLC | 67877-548 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | DIRECT RX | 72189-259 |
| cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-5811 |