What is NDC 69292-516?

69292-516 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 200 mg/1 tablet, film coated, listed with the FDA by Amici Pharmaceuticals, LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amici Pharmaceuticals, LLC., NDC labeler code 69292. 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 69292-516

NDC codes

FDA NDC Directory

Product NDC (as listed)69292-516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69292-0516Add 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	Copy
69292-516-01	6929205160169292051601	100 TABLET, FILM COATED in 1 BOTTLE (69292-516-01)Marketed from Dec 21, 2022
69292-516-50	6929205165069292051650	500 TABLET, FILM COATED in 1 BOTTLE (69292-516-50)Marketed from Dec 21, 2022

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: Amici Pharmaceuticals, LLC.NDC labeler code 69292
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210568
Marketing start: Dec 21, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 69292-516_157c18ee-7809-4e05-8caa-0359ef50142eSPL ID 157c18ee-7809-4e05-8caa-0359ef50142eSPL set ID 9d6d7f50-9838-47e3-8214-53e2dbeeadeaRxCUI 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

N469292051601 followed by a unit qualifier and the quantity

Package 69292-0516-01. 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 Jul 13, 2023.

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, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69292-516

What is NDC 69292-516?: 69292-516 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 200 mg/1 tablet, film coated, listed with the FDA by Amici Pharmaceuticals, LLC.. 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?: Amici Pharmaceuticals, LLC., NDC labeler code 69292. 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 100 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-559	67877-0559-0167877-0559-0567877-0559-20
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-560	67877-0560-0167877-0560-0567877-0560-20

All 27 Cefpodoxime Proxetil NDCs

Other NDCs under ANDA 210568

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

FDA NDC Directory listings under ANDA 210568
Product	Strength	Form · route	Labeler	Product NDC
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3441
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-559
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	Amici Pharmaceuticals, LLC.	69292-514
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-560
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2331
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2332
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4676
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3616
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-084
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-083
Cefpodoxime Proxetil	Cefpodoxime proxetil 100 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-878
Cefpodoxime Proxetil	Cefpodoxime proxetil 200 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-879