Prescription drug · ANDA
Cefdinir NDC 68071-3998
Cefdinir 300 mg/1 · Capsule · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3998-2 | 68071399802 | 2 CAPSULE in 1 BOTTLE (68071-3998-2)Marketed from May 6, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065434
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 68071-3998_5128bf5c-27c8-8a0a-e063-6394a90a8ffaSPL ID 5128bf5c-27c8-8a0a-e063-6394a90a8ffaSPL set ID 5128dc70-f3cd-25c0-e063-6294a90aa52fRxCUI 200346UNII CI0FAO63WCUPC 0368071399820
- 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
N468071399802followed by a unit qualifier and the quantityPackage 68071-3998-02. 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 capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated micro…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065434
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. | 68788-8404 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2719 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-177 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Direct_Rx | 72189-423 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5145 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-550 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7339 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-054 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-959 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-964 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-061 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1880 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 57237-099 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4007 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-362 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-224 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4946 |