Prescription drug · ANDA
Cefadroxil NDC 43063-553
Cefadroxil 500 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-553-10 | 43063055310 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-10)Marketed from Sep 11, 2012 | |
| 43063-553-14 | 43063055314 | 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-14)Marketed from Sep 11, 2012 | |
| 43063-553-20 | 43063055320 | 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-20)Marketed from Sep 11, 2012 | |
| 43063-553-28 | 43063055328 | 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-28)Marketed from Sep 11, 2012 |
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)
- Cefadroxil
- Generic name (nonproprietary)
- cefadroxil
- Active ingredients
- Cefadroxil — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065392
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 43063-553_2f3a95a9-25cd-d525-e063-6394a90a460fSPL ID 2f3a95a9-25cd-d525-e063-6394a90a460fSPL set ID f5bbbf87-f059-4bbd-aea9-27d31462654fRxCUI 309049UNII 280111G160UPC 0343063553145
- 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
N443063055310followed by a unit qualifier and the quantityPackage 43063-0553-10. 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 Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. Howe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065392
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 |
|---|---|---|---|---|
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0432 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Direct_Rx | 72189-445 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4690 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-180 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8261 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-0491 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Proficient Rx LP | 63187-883 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3580 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9456 |