NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0005Add 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 NDC11-digit (billing)PackageCopy
80425-0005-1804250005018042500050128 CAPSULE in 1 BOTTLE (80425-0005-1)Marketed from Jan 11, 2006
80425-0005-2804250005028042500050240 CAPSULE in 1 BOTTLE (80425-0005-2)Marketed from Jan 11, 2006
80425-0005-380425000503804250005036 CAPSULE in 1 BOTTLE (80425-0005-3)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 065229
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 80425-0005_0f3ed48b-be43-1ecb-e063-6294a90a6eb0SPL ID 0f3ed48b-be43-1ecb-e063-6294a90a6eb0SPL set ID af10128f-021a-14b7-e053-2a95a90a4365RxCUI 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

N480425000501 followed by a unit qualifier and the quantity

Package 80425-0005-01. 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 .

Indications (excerpt from the label)

1. Indications and Usage Section 1 INDICATIONS AND USAGE 1.1 Respiratory Tract Infections Cephalexin capsules USP 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 USP 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 USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-po…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0005

What is NDC 80425-0005?
80425-0005 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by ADVANCED RX PHARMACY OF TENNESSEE, LLC. It has 3 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CephalexinCephalexin 500 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-414368788-4143-0168788-4143-0268788-4143-03+6 more
CephalexinCephalexin 250 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-416768788-4167-0268788-4167-0368788-4167-04+3 more
CephalexinCephalexin 125 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited59651-32259651-0322-0159651-0322-02
CephalexinCephalexin 250 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited59651-32359651-0323-0159651-0323-02
CephalexinCephalexin 500 mg/1CapsuleOralCoupler LLC67046-124567046-1245-03
CephalexinCephalexin 250 mg/1CapsuleOralAVKARE42291-00642291-0006-50
CephalexinCephalexin 500 mg/1CapsuleOralAVKARE42291-00742291-0007-50
CephalexinCephalexin 500 mg/1CapsuleOralNorthwind Health Company, LLC82868-09582868-0095-1082868-0095-2082868-0095-21+3 more
CephalexinCephalexin 250 mg/5mLFor suspensionOralREMEDYREPACK INC.70518-451170518-4511-00
CephalexinCephalexin 250 mg/1CapsuleOralCoupler, LLC67046-153367046-1533-03

All 184 Cephalexin NDCs

Other NDCs under ANDA 065229

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

FDA NDC Directory listings under ANDA 065229
ProductStrengthForm · routeLabelerProduct NDC
CephalexinCephalexin 500 mg/1CapsuleOralProficient Rx LP63187-046
CephalexinCephalexin 500 mg/1CapsuleOralCoupler LLC67046-1245
CephalexinCephalexin 500 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4406
CephalexinCephalexin 250 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4516
CephalexinCephalexin 250 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-5241
CephalexinCephalexin 250 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-121
CephalexinCephalexin 500 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-122
CephalexinCephalexin 500 mg/1CapsuleOralREMEDYREPACK INC.70518-3448
CephalexinCephalexin 500 mg/1CapsuleOralREMEDYREPACK INC.70518-3857
CephalexinCephalexin 500 mg/1CapsuleOralAsclemed USA, Inc.76420-052
CephalexinCephalexin 250 mg/1CapsuleOralAsclemed USA, Inc.76420-287
CephalexinCephalexin 500 mg/1CapsuleOralAsclemed USA, Inc.76420-288
CephalexinCephalexin 500 mg/1CapsuleOralAsclemed USA, Inc.76420-736
CephalexinCephalexin 500 mg/1CapsuleOralAsclemed USA, Inc76420-831
CephalexinCephalexin 500 mg/1CapsuleOralADVANCED RX PHARMACY OF TENNESSEE, LLC80425-0006
CephalexinCephalexin 500 mg/1CapsuleOralSportpharm LLC85766-004

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