Prescription drug · ANDA
Cefprozil NDC 0093-1077
Cefprozil 250 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-1077-01 | 00093107701 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-1077-01)Marketed from Dec 23, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065208
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-1077_c226712f-00c2-407f-8b40-5ed1be54dfb8SPL ID c226712f-00c2-407f-8b40-5ed1be54dfb8SPL set ID 3391de8b-7bc9-4624-a5c4-836135b39d99RxCUI 197452, 197453UNII 4W0459ZA4V
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
N400093107701followed by a unit qualifier and the quantityPackage 00093-1077-01. 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 tablets are 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 fever are no…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065208
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 |
|---|---|---|---|---|
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-1078 |