Prescription drug · ANDA
Cefpodoxime Proxetil NDC 16714-395
Cefpodoxime proxetil 200 mg/1 · Tablet, Film coated · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-395-01 | 16714039501 | 20 TABLET, FILM COATED in 1 BOTTLE (16714-395-01)Marketed from Jun 11, 2007 |
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)
- Cefpodoxime Proxetil
- Generic name (nonproprietary)
- cefpodoxime proxetil
- Active ingredients
- Cefpodoxime proxetil — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065370
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 16714-395_518e9779-a683-436e-a032-c6a0df0a0de2SPL ID 518e9779-a683-436e-a032-c6a0df0a0de2SPL set ID 4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9RxCUI 309076, 309078UNII 2TB00A1Z7N
- 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
N416714039501followed by a unit qualifier and the quantityPackage 16714-0395-01. 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 Cefpodoxime proxetil 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. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes , Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065370
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 |
|---|---|---|---|---|
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Cronus Pharma LLC | 69043-006 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Cronus Pharma LLC | 69043-007 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-394 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-095 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-096 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2317 |