NDC codes

FDA NDC Directory
Product NDC (as listed)59651-783Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0783Add 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
59651-783-0159651078301100 TABLET, FILM COATED in 1 BOTTLE (59651-783-01)Marketed from Sep 27, 2024

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)
Cephalexin
Generic name (nonproprietary)
cephalexin
Active ingredients
Cephalexin — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218817
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 59651-783_e46059e1-3ce9-4a3c-80ce-464b140600ceSPL ID e46059e1-3ce9-4a3c-80ce-464b140600ceSPL set ID e46059e1-3ce9-4a3c-80ce-464b140600ceRxCUI 197454, 309115UNII 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

N459651078301 followed by a unit qualifier and the quantity

Package 59651-0783-01. 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)

INDICATIONS AND USAGE Cephalexin tablets are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes Otitis media due to susceptible isolates of Streptococcu pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella Catarrhalis. Skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus , and Streptococcus pyogenes . Bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus Mir…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-783

What is NDC 59651-783?
59651-783 is the product NDC for Cephalexin, Cephalexin 250 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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+2 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 218817

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

FDA NDC Directory listings under ANDA 218817
ProductStrengthForm · routeLabelerProduct NDC
CephalexinCephalexin 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-784

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