Prescription drug · ANDA
Cefdinir NDC 68788-8323
Cefdinir 300 mg/1 · Capsule · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8323-2 | 68788832302 | 20 CAPSULE in 1 BOTTLE (68788-8323-2)Marketed from Jan 23, 2023 |
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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065264
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 68788-8323_cfe64312-8c09-4ea9-ac4d-2e4a017452d8SPL ID cfe64312-8c09-4ea9-ac4d-2e4a017452d8SPL set ID 8787ea15-bf90-4178-9b0f-08b075f1aa3dRxCUI 200346UNII 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
N468788832302followed by a unit qualifier and the quantityPackage 68788-8323-02. 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 capsules and other antibacterial drugs, cefdinir capsules 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 are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the des…
Excerpt only. Read the full label for complete information.
About NDC 68788-8323
- What is NDC 68788-8323?
- 68788-8323 is the product NDC for Cefdinir, Cefdinir 300 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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?
- 77 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 | DirectRx | 72189-308 | 72189-0308-1472189-0308-20 |
Other NDCs under ANDA 065264
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 | Lupin Pharmaceuticals, Inc. | 68180-711 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1033 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4856 |