Prescription drug · ANDA
Cefdinir NDC 72189-186
Cefdinir 250 mg/5mL · Powder, For suspension · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-186-32 | 72189018632 | 60 mL in 1 BOTTLE (72189-186-32)Marketed from Apr 12, 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 — 250 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- DIRECT RX
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065473
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 72189-186_2c4ea169-07c6-6bde-e063-6394a90a0890SPL ID 2c4ea169-07c6-6bde-e063-6394a90a0890SPL set ID 982d0f53-20bc-1cb4-e053-2995a90ad33cRxCUI 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
N472189018632followed by a unit qualifier and the quantityPackage 72189-0186-32. 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)
suspension and other antibacterial drugs, cefdinir for oral suspension 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 microorganisms in the conditions listed below. Adults and Adolescents: Community-Acquir…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065473
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 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-5106 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-219 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-218 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6417 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-405 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | DIRECT RX | 72189-185 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals, Inc. | 68071-5318 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-835 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-7844 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4970 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-2735 |