Prescription drug · ANDA
Cefadroxil NDC 68180-182
Cefadroxil 500 mg/5mL · Powder, For suspension · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-182-02 | 68180018202 | 75 mL in 1 BOTTLE (68180-182-02)Marketed from Apr 23, 2008 | |
| 68180-182-03 | 68180018203 | 100 mL in 1 BOTTLE (68180-182-03)Marketed from Apr 23, 2008 |
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/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065396
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 68180-182_3818bd15-cf3a-4b07-bef5-57169a33a170SPL ID 3818bd15-cf3a-4b07-bef5-57169a33a170SPL set ID 27009a05-4d2b-4618-be76-39f348240edaRxCUI 105171, 309048UNII 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
N468180018202followed by a unit qualifier and the quantityPackage 68180-0182-02. 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 Cefadroxil for oral suspension USP 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 monohydrate is generally effective in the eradication of streptococci from the oropha…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065396
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 250 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-181 |