Prescription drug · ANDA
Cefprozil NDC 68180-402
Cefprozil 250 mg/5mL · Powder, For suspension · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-402-01 | 68180040201 | 50 mL in 1 BOTTLE (68180-402-01)Marketed from Dec 1, 2005 | |
| 68180-402-02 | 68180040202 | 75 mL in 1 BOTTLE (68180-402-02)Marketed from Dec 1, 2005 | |
| 68180-402-03 | 68180040203 | 100 mL in 1 BOTTLE (68180-402-03)Marketed from Dec 1, 2005 |
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)
- Cefprozil
- Generic name (nonproprietary)
- cefprozil
- Active ingredients
- Cefprozil — 250 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 065261
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-402_45d1a412-407b-48d4-be64-b9c7ec3c5205SPL ID 45d1a412-407b-48d4-be64-b9c7ec3c5205SPL set ID 3ec55c0a-1456-412e-972f-352b3135c8f2RxCUI 309080, 309081UNII 4W0459ZA4VUPC 0368180401032, 0368180402039
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
N468180040201followed by a unit qualifier and the quantityPackage 68180-0402-01. 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 Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Upper Respiratory Tract: Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes . NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065261
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.