FDA.reportPublic FDA data

Cephalexin

Product NDC
53002-2181
11-digit product format
530022181
Labeler code
53002
Product ID
53002-2181_bc53ef7e-3d8b-4fef-99eb-3b8d3509aac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2181-12025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-22025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-32025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-42025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-52025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-62025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-92025-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-12023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-22023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-32023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-42023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-52023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-62023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-92023-06-07C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-12023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-22023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-32023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-42023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-52023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-62023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-92023-01-30C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-12020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-22020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-32020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-42020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-52020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-62020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-92020-12-15C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-12020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-22020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-32020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-42020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-52020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-62020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
53002-2181-92020-01-31C16284748780-19d75b9d0-e8a5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2181-1Cephalexin500 in 1 BOTTLECAPSULE5008
53002-2181-2Cephalexin500 in 1 BOTTLECAPSULE5008
53002-2181-3Cephalexin500 in 1 BOTTLECAPSULE5008
53002-2181-4Cephalexin500 in 1 BOTTLECAPSULE5008
53002-2181-5Cephalexin500 in 1 BOTTLECAPSULE5008
53002-2181-6Cephalexin500 in 1 BOTTLECAPSULE5008
53002-2181-9Cephalexin500 in 1 BOTTLECAPSULE5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2181CEPHALEXIN CAPSULE CEPHALEXIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 7 package rows20230609_3b1a58b4-8a3f-4053-ad60-eff02200b178.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN3b1a58b4-8a3f-4053-ad60-eff02200b1788
309114cephalexin 500 MG Oral CapsulePSN3b1a58b4-8a3f-4053-ad60-eff02200b1788
309113cephalexin 50 MG/ML Oral SuspensionSCD3b1a58b4-8a3f-4053-ad60-eff02200b1788
309114cephalexin 500 MG Oral CapsuleSCD3b1a58b4-8a3f-4053-ad60-eff02200b1788
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY3b1a58b4-8a3f-4053-ad60-eff02200b1788
309113cefalexin 50 MG/ML Oral SuspensionSY3b1a58b4-8a3f-4053-ad60-eff02200b1788
309113cephalexin 250 MG per 5 ML Oral SuspensionSY3b1a58b4-8a3f-4053-ad60-eff02200b1788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2181-153002218101500 CAPSULE in 1 BOTTLE (53002-2181-1) 500 capsule2018-10-010000-00-00NoNoCurrent
53002-2181-253002218102500 CAPSULE in 1 BOTTLE (53002-2181-2) 500 capsule2018-10-010000-00-00NoNoCurrent
53002-2181-353002218103500 CAPSULE in 1 BOTTLE (53002-2181-3) 500 capsule2018-10-010000-00-00NoNoCurrent
53002-2181-453002218104500 CAPSULE in 1 BOTTLE (53002-2181-4) 500 capsule2018-10-010000-00-00NoNoCurrent
53002-2181-553002218105500 CAPSULE in 1 BOTTLE (53002-2181-5) 500 capsule2018-10-010000-00-00NoNoCurrent
53002-2181-653002218106500 CAPSULE in 1 BOTTLE (53002-2181-6) 500 capsule2018-10-010000-00-00NoNoCurrent
53002-2181-953002218109500 CAPSULE in 1 BOTTLE (53002-2181-9) 500 capsule2018-10-010000-00-00NoNoCurrent