Prescription drug · ANDA
Cefdinir NDC 76420-328
Cefdinir 250 mg/5mL · Powder, For suspension · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-328-01 | 7642003280176420032801 | 100 mL in 1 BOTTLE (76420-328-01)Marketed from Apr 19, 2025 | |
| 76420-328-60 | 7642003286076420032860 | 60 mL in 1 BOTTLE (76420-328-60)Marketed from Apr 19, 2025 |
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
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065259
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 76420-328_331b63bf-fd36-155d-e063-6294a90aec23SPL ID 331b63bf-fd36-155d-e063-6294a90aec23SPL set ID e90660c8-2714-4592-aeaa-bc9ceb26057cRxCUI 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
N476420032801followed by a unit qualifier and the quantityPackage 76420-0328-01. 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 for oral 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 b…
Excerpt only. Read the full label for complete information.
About NDC 76420-328
- What is NDC 76420-328?
- 76420-328 is the product NDC for Cefdinir, Cefdinir 250 mg/5mL powder, for suspension, listed with the FDA by Asclemed USA, Inc.. 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 065259
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 | Preferred Pharmaceuticals Inc. | 68788-4106 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals, Inc. | 68071-3806 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-3609 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | DIRECT RX | 72189-043 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-722 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-3723 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-380 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-723 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-3403 |
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6171 |
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | Asclemed USA, Inc. | 76420-327 |