What is NDC 68071-3616?

68071-3616 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 100 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 68071-3616

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3616Add 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
68071-3616-4	6807136160468071361604	14 TABLET, FILM COATED in 1 BOTTLE (68071-3616-4)Marketed from Jun 19, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210568
Marketing start: Mar 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 68071-3616_1b40454e-994c-39d8-e063-6394a90a97cbSPL ID 1b40454e-994c-39d8-e063-6394a90a97cbSPL set ID 1b405104-650b-c8e3-e063-6294a90a9e8aRxCUI 309076UNII 2TB00A1Z7NUPC 0368071361643
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

N468071361604 followed by a unit qualifier and the quantity

Package 68071-3616-04. 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 Jun 19, 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, 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 68071-3616

What is NDC 68071-3616?: 68071-3616 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 100 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 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
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 200 mg/1	Tablet, Film coatedOral	Amici Pharmaceuticals, LLC.	69292-516
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 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