Prescription drug · ANDA
Cefpodoxime Proxetil NDC 65862-141
Cefpodoxime proxetil 100 mg/5mL · Granule, For suspension · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-141-01 | 65862014101 | 1 BOTTLE in 1 CARTON (65862-141-01) / 100 mL in 1 BOTTLEMarketed from Jun 8, 2007 | |
| 65862-141-50 | 65862014150 | 1 BOTTLE in 1 CARTON (65862-141-50) / 50 mL in 1 BOTTLEMarketed from Jun 8, 2007 | |
| 65862-141-75 | 65862014175 | 1 BOTTLE in 1 CARTON (65862-141-75) / 75 mL in 1 BOTTLEMarketed from Jun 8, 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 — 100 mg/5mL
- Dosage form
- Granule, For suspension
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065409
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 65862-141_95331369-8343-4244-8d82-03a1bc4af0c0SPL ID 95331369-8343-4244-8d82-03a1bc4af0c0SPL set ID 63777889-d306-4fc3-88da-b24859040ef4RxCUI 309077, 309079UNII 2TB00A1Z7NUPC 0365862140012, 0365862141019
- 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
N465862014101followed by a unit qualifier and the quantityPackage 65862-0141-01. 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 065409
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 50 mg/5mL | Granule, For suspensionOral | NorthStar Rx LLC | 16714-402 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/5mL | Granule, For suspensionOral | NorthStar Rx LLC | 16714-403 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 50 mg/5mL | Granule, For suspensionOral | Rising Pharma Holdings, Inc. | 64980-402 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/5mL | Granule, For suspensionOral | Rising Pharma Holdings, Inc. | 64980-403 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 50 mg/5mL | Granule, For suspensionOral | Aurobindo Pharma Limited | 65862-140 |