FDA.reportPublic FDA data

Cephalexin

Product NDC
70934-065
11-digit product format
709340065
Labeler code
70934
Product ID
70934-065_a12a960c-0d00-0caf-e053-2a95a90a6548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065229
Marketing category
ANDA
Marketing start
2018-01-18
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-065-102022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-142022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-202022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-212022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-282022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-302022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-402022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-942022-01-28C16284748780-1d6a99b39-3897-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-065-10Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE105
70934-065-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE145
70934-065-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE205
70934-065-21Cephalexin1 in 1 BOTTLE, PLASTICCAPSULE15
70934-065-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE285
70934-065-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE305
70934-065-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE405
70934-065-94Cephalexin30 in 1 DOSE PACKCAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-065-20EA - Each70934-065af1935e4-ef21-4d06-90ba-37a7b8fc3d8312022-11-07
70934-065-30EA - Each70934-065394e68c8-0a70-4b35-81df-b51b6b1089fe12022-01-06
70934-065-40EA - Each70934-0658c244c1a-c1d8-4ab4-894b-4e20a8554f2c12021-10-08
70934-065-94EA - Each70934-065b5ea0d9a-7035-4e26-a498-f517f8dc946912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-065CEPHALEXIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]5Legacy NDC, 8 package rows20200319_6440351e-065f-59da-e053-2a91aa0aa4c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN6440351e-065f-59da-e053-2a91aa0aa4c55
309114cephalexin 500 MG Oral CapsuleSCD6440351e-065f-59da-e053-2a91aa0aa4c55
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6440351e-065f-59da-e053-2a91aa0aa4c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-065-107093400651010 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-10) 10 capsule2020-02-050000-00-00NoNoCurrent
70934-065-147093400651414 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-14) 14 capsule2020-02-050000-00-00NoNoCurrent
70934-065-207093400652020 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-20) 20 capsule2019-12-120000-00-00NoNoCurrent
70934-065-21709340065211 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-21) 1 capsule2020-02-050000-00-00NoNoCurrent
70934-065-287093400652828 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-28) 28 capsule2020-02-050000-00-00NoNoCurrent
70934-065-307093400653030 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-30) 30 capsule2019-11-060000-00-00NoNoCurrent
70934-065-407093400654040 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-40) 40 capsule2019-09-090000-00-00NoNoCurrent
70934-065-947093400659430 CAPSULE in 1 DOSE PACK (70934-065-94) 30 capsule2018-01-180000-00-00NoNoCurrent