NDC codes

FDA NDC Directory
Product NDC (as listed)68071-4355Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-4355Add 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
68071-4355-16807143550121 CAPSULE in 1 BOTTLE (68071-4355-1)Marketed from Mar 23, 2018
68071-4355-36807143550330 CAPSULE in 1 BOTTLE (68071-4355-3)Marketed from Mar 23, 2018
68071-4355-46807143550414 CAPSULE in 1 BOTTLE (68071-4355-4)Marketed from Mar 23, 2018
68071-4355-76807143550740 CAPSULE in 1 BOTTLE (68071-4355-7)Marketed from Mar 23, 2018
68071-4355-86807143550828 CAPSULE in 1 BOTTLE (68071-4355-8)Marketed from Mar 23, 2018
68071-4355-96807143550910 CAPSULE in 1 BOTTLE (68071-4355-9)Marketed from Oct 25, 2022

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
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090836
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13SPL ID 1a55498c-d3ae-b7f7-e063-6394a90adb13SPL set ID 681c235f-6dee-1401-e053-2991aa0addc0RxCUI 309114UNII OBN7UDS42YUPC 0368071435580
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

N468071435501 followed by a unit qualifier and the quantity

Package 68071-4355-01. 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)

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 68071-4355

What is NDC 68071-4355?
68071-4355 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 6 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?
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 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 090836

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

FDA NDC Directory listings under ANDA 090836
ProductStrengthForm · routeLabelerProduct NDC
CephalexinCephalexin 250 mg/1CapsuleOralMajor Pharmaceuticals0904-7336
CephalexinCephalexin 500 mg/1CapsuleOralMajor Pharmaceuticals0904-7337
CephalexinCephalexin 500 mg/1CapsuleOralQPharma Inc42708-070
CephalexinCephalexin 250 mg/1CapsuleOralQPharma Inc42708-145
CephalexinCephalexin 250 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-497
CephalexinCephalexin 500 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-536
CephalexinCephalexin 500 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-634
CephalexinCephalexin 250 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-678
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-3199
CephalexinCephalexin 250 mg/1CapsuleOralA-S Medication Solutions50090-3202
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-3252
CephalexinCephalexin 250 mg/1CapsuleOralA-S Medication Solutions50090-3291
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-3427
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-5948
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-7026
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-7027
CephalexinCephalexin 500 mg/1CapsuleOralA-S Medication Solutions50090-7223
CephalexinCephalexin 250 mg/1CapsuleOralAvPAK50268-151
CephalexinCephalexin 500 mg/1CapsuleOralAvPAK50268-152
CephalexinCephalexin 250 mg/1CapsuleOralAmerican Health Packaging60687-152

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