Prescription drug · ANDA
Cefadroxil NDC 63629-7988
Cefadroxil 500 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-7988-1 | 63629798801 | 30 CAPSULE in 1 BOTTLE (63629-7988-1)Marketed from Apr 3, 2024 |
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)
- Cefadroxil
- Generic name (nonproprietary)
- cefadroxil
- Active ingredients
- Cefadroxil — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065352
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 63629-7988_d87bf519-36f3-4e11-83a1-26af4bbeb279SPL ID d87bf519-36f3-4e11-83a1-26af4bbeb279SPL set ID 9c3bed82-6df0-4643-944a-a826f7dc018fRxCUI 309049UNII 280111G160
- 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
N463629798801followed by a unit qualifier and the quantityPackage 63629-7988-01. 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 Cefadroxil is 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 is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the e…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065352
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 | Preferred Pharmaceuticals Inc. | 68788-8479 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3597 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | DIRECT RX | 72189-103 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0198 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4515 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6050 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5234 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Direct_Rx | 72189-506 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-2221 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-595 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 57237-096 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-388 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4938 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | RedPharm Drug, Inc. | 67296-1727 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-085 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7987 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0400 |
| Cefadroxil | Cefadroxil 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8253 |