Prescription drug · ANDA
Cefpodoxime Proxetil NDC 64980-403
Cefpodoxime proxetil 100 mg/5mL · Granule, For suspension · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-403-10 | 6498004031064980040310 | 1 BOTTLE in 1 CARTON (64980-403-10) / 100 mL in 1 BOTTLEMarketed from Jun 8, 2007 | |
| 64980-403-50 | 6498004035064980040350 | 1 BOTTLE in 1 CARTON (64980-403-50) / 50 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
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- 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 64980-403_803b37ff-46c6-4dcb-9d9f-a118c4c4601bSPL ID 803b37ff-46c6-4dcb-9d9f-a118c4c4601bSPL set ID edf589b2-f796-4522-a5e6-2bd0a833922fRxCUI 309077, 309079UNII 2TB00A1Z7NUPC 0364980403504, 0364980402507
- 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
N464980040310followed by a unit qualifier and the quantityPackage 64980-0403-10. 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.
About NDC 64980-403
- What is NDC 64980-403?
- 64980-403 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 100 mg/5mL granule, for suspension, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefpodoxime Proxetil.
- What is the active ingredient?
- Cefpodoxime proxetil.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefpodoxime Proxetil?
- 26 other product NDCs are listed under this name. See all Cefpodoxime Proxetil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefpodoxime Proxetil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4676 | 70518-4676-00 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2331 | 67296-2331-01 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-878 | 67877-0878-0167877-0878-0567877-0878-20 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3616 | 68071-3616-04 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2332 | 67296-2332-03 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-879 | 67877-0879-0167877-0879-0567877-0879-20 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3441 | 68071-3441-02 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Amici Pharmaceuticals, LLC. | 69292-514 | 69292-0514-0169292-0514-50 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Amici Pharmaceuticals, LLC. | 69292-516 | 69292-0516-0169292-0516-50 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-559 | 67877-0559-0167877-0559-0567877-0559-20 |
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 50 mg/5mL | Granule, For suspensionOral | Aurobindo Pharma Limited | 65862-140 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/5mL | Granule, For suspensionOral | Aurobindo Pharma Limited | 65862-141 |