NDC codes

FDA NDC Directory
Product NDC (as listed)42291-209Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0209Add 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
42291-209-5042291020950500 CAPSULE in 1 BOTTLE (42291-209-50)Marketed from Aug 11, 2011

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 — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062713
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 42291-209_57c64610-7957-082e-e063-6294a90ae472SPL ID 57c64610-7957-082e-e063-6294a90ae472SPL set ID 03f6f6ae-66bc-6819-8ba9-7c9c3fbef90dRxCUI 309112, 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

N442291020950 followed by a unit qualifier and the quantity

Package 42291-0209-50. 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)

Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by suscepti…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-209

What is NDC 42291-209?
42291-209 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by AvKARE. 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?
AvKARE, NDC labeler code 42291. 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?
185 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 250 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited59651-32359651-0323-0159651-0323-02
CephalexinCephalexin 125 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited59651-32259651-0322-0159651-0322-02
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 186 Cephalexin NDCs

Other NDCs under ANDA 062713

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

FDA NDC Directory listings under ANDA 062713
ProductStrengthForm · routeLabelerProduct NDC
CephalexinCephalexin 250 mg/1CapsuleOralAvKARE42291-208

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