Prescription drug · ANDA
Cefdinir NDC 65862-218
Cefdinir 125 mg/5mL · Powder, For suspension · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-218-01 | 6586202180165862021801 | 1 BOTTLE in 1 CARTON (65862-218-01) / 100 mL in 1 BOTTLEMarketed from Dec 14, 2007 | |
| 65862-218-60 | 6586202186065862021860 | 1 BOTTLE in 1 CARTON (65862-218-60) / 60 mL in 1 BOTTLEMarketed from Dec 14, 2007 |
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
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7SPL ID 9cfbe4a1-045c-489f-8ca7-9d595997dab7SPL set ID 06fbdb63-d32f-4212-9962-f1de15597ddaRxCUI 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
N465862021801followed by a unit qualifier and the quantityPackage 65862-0218-01. 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 AND 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 …
Excerpt only. Read the full label for complete information.
About NDC 65862-218
- What is NDC 65862-218?
- 65862-218 is the product NDC for Cefdinir, Cefdinir 125 mg/5mL powder, for suspension, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefdinir.
- What is the active ingredient?
- Cefdinir.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefdinir?
- 80 other product NDCs are listed under this name. See all Cefdinir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefdinir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-4106 | 68788-4106-01 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7563 | 00904-7563-04 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4169 | 70518-4169-0070518-4169-0170518-4169-02+1 more |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-059 | 82868-0059-20 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | AvKARE | 42291-043 | 42291-0043-60 |
| Cefdinir | Cefdinir monohydrate 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8655 | 68788-8655-01 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | American Health Packaging | 60687-699 | 60687-0699-21 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8404 | 68788-8404-02 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Direct_Rx | 72189-423 | 72189-0423-1472189-0423-20 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8323 | 68788-8323-02 |
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 | A-S Medication Solutions | 50090-2735 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6417 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-835 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-219 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4970 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-5106 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals, Inc. | 68071-5318 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-7844 |
| 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 250 mg/5mL | Powder, For suspensionOral | DIRECT RX | 72189-186 |