What is NDC 65862-095?

65862-095 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 100 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cefpodoxime Proxetil NDC 65862-095

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0095Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65862-095-01	6586200950165862009501	100 TABLET, FILM COATED in 1 BOTTLE (65862-095-01)Marketed from Jun 11, 2007
65862-095-20	6586200952065862009520	20 TABLET, FILM COATED in 1 BOTTLE (65862-095-20)Marketed from Jun 11, 2007
65862-095-25	6586200952565862009525	250 TABLET, FILM COATED in 1 BOTTLE (65862-095-25)Marketed from Oct 6, 2023
65862-095-99	6586200959965862009599	1000 TABLET, FILM COATED in 1 BOTTLE (65862-095-99)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 — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065370
Marketing start: Jun 11, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 65862-095_12ee6554-adfc-4c3b-b87e-3568576359a6SPL ID 12ee6554-adfc-4c3b-b87e-3568576359a6SPL set ID c36f2137-98bb-4583-89f7-6bce9582c465RxCUI 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

N465862009501 followed by a unit qualifier and the quantity

Package 65862-0095-01. 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 Jan 3, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 65862-095

What is NDC 65862-095?: 65862-095 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 100 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cefpodoxime Proxetil NDCs
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

All 27 Cefpodoxime Proxetil NDCs

Other NDCs under ANDA 065370

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 065370
Product	Strength	Form · route	Labeler	Product NDC
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-394
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-395
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2317
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