What is NDC 80425-0004?

80425-0004 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by ADVANCED RX PHARMACY OF TENNESSEE, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

ADVANCED RX PHARMACY OF TENNESSEE, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cephalexin?

183 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cephalexin NDC 80425-0004 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0004Add 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
80425-0004-1	8042500040180425000401	28 CAPSULE in 1 BOTTLE (80425-0004-1)Marketed from Sep 14, 2022
80425-0004-2	8042500040280425000402	40 CAPSULE in 1 BOTTLE (80425-0004-2)Marketed from Sep 14, 2022
80425-0004-3	8042500040380425000403	6 CAPSULE in 1 BOTTLE (80425-0004-3)Marketed from Jan 18, 2024
80425-0004-4	8042500040480425000404	5 CAPSULE in 1 BOTTLE (80425-0004-4)Marketed from Jan 18, 2024
80425-0004-5	8042500040580425000405	14 CAPSULE in 1 BOTTLE (80425-0004-5)Marketed from Jan 18, 2024
80425-0004-6	8042500040680425000406	20 CAPSULE in 1 BOTTLE (80425-0004-6)Marketed from Jan 18, 2024
80425-0004-7	8042500040780425000407	30 CAPSULE in 1 BOTTLE (80425-0004-7)Marketed from Jan 18, 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): Cephalexin
Generic name (nonproprietary): cephalexin
Active ingredients: Cephalexin — 500 mg/1
Dosage form: Capsule
Route: Oral
Labeler: ADVANCED RX PHARMACY OF TENNESSEE, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065253
Marketing start: Sep 14, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209SPL ID 137a5de3-ab83-e2ab-e063-6294a90a6209SPL set ID af49507d-254f-296d-e053-2a95a90ad263RxCUI 309114UNII OBN7UDS42Y
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

N480425000401 followed by a unit qualifier and the quantity

Package 80425-0004-01. 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 Mar 12, 2024.

Indications (excerpt from the label)

1. Indications and Usage 1.1 Respiratory Tract Infections Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and S…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0004

What is NDC 80425-0004?: 80425-0004 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by ADVANCED RX PHARMACY OF TENNESSEE, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cephalexin.
What is the active ingredient?: Cephalexin.
Who is the labeler?: ADVANCED RX PHARMACY OF TENNESSEE, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cephalexin?: 183 other product NDCs are listed under this name. See all Cephalexin 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 Cephalexin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4143	68788-4143-0168788-4143-0268788-4143-03+6 more
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4167	68788-4167-0268788-4167-0368788-4167-04+3 more
Cephalexin	Cephalexin 125 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	59651-322	59651-0322-0159651-0322-02
Cephalexin	Cephalexin 250 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	59651-323	59651-0323-0159651-0323-02
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Coupler LLC	67046-1245	67046-1245-03
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	AVKARE	42291-006	42291-0006-50
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	AVKARE	42291-007	42291-0007-50
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-095	82868-0095-1082868-0095-2082868-0095-21+3 more
Cephalexin	Cephalexin 250 mg/5mL	For suspensionOral	REMEDYREPACK INC.	70518-4511	70518-4511-00
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Coupler, LLC	67046-1533	67046-1533-03

All 184 Cephalexin NDCs

Other NDCs under ANDA 065253

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

FDA NDC Directory listings under ANDA 065253
Product	Strength	Form · route	Labeler	Product NDC
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-0079
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-0080
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-0081
Cephalexin	Cephalexin 750 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-728
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Chartwell RX, LLC	62135-710
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-4219
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-5740
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-5741
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-5742
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-7621
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-018
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-019
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Coupler, LLC	67046-1533
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-3532
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-3538
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	NuCare Pharmaceuticals, Inc.	68071-3680
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	NuCare Pharmaceuticals, Inc.	68071-3740
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4167
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8538
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Cronus Pharma LLC	69043-008

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