What is NDC 69043-007?

69043-007 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 200 mg/1 tablet, film coated, listed with the FDA by Cronus Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cronus Pharma LLC, NDC labeler code 69043. 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 69043-007

NDC codes

FDA NDC Directory

Product NDC (as listed)69043-007Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69043-0007Add 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
69043-007-01	6904300070169043000701	100 TABLET, FILM COATED in 1 BOTTLE (69043-007-01)Marketed from Jun 11, 2007
69043-007-25	6904300072569043000725	250 TABLET, FILM COATED in 1 BOTTLE (69043-007-25)Marketed from Oct 6, 2023

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: Cronus Pharma LLCNDC labeler code 69043
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 69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cfSPL ID 36f0759f-b50b-4a49-869b-d73f5ad7d8cfSPL set ID bc9c338c-1fc7-4bc2-a357-a78e433cbe9dRxCUI 309076, 309078UNII 2TB00A1Z7NUPC 0369043007019
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

N469043000701 followed by a unit qualifier and the quantity

Package 69043-0007-01. 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 4, 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 69043-007

What is NDC 69043-007?: 69043-007 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 200 mg/1 tablet, film coated, listed with the FDA by Cronus Pharma 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?: Cronus Pharma LLC, NDC labeler code 69043. 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 100 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-095
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