FDA.reportPublic FDA data

Cephalexin

Product NDC
42708-017
11-digit product format
427080017
Labeler code
42708
Product ID
42708-017_45b43457-b9f1-09a2-e063-6294a90a698d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
QPharma Inc
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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
42708-017-282021-03-12C16284748780-1ba0f9c33-1c0d-a910-e053-dadaa90a0b85These 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
42708-017-282021-01-29C16284748780-1ba0f9c33-1c0d-a910-e053-dadaa90a0b85These 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
42708-017-28Cephalexin28 in 1 BOTTLECAPSULE287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-017CEPHALEXIN CAPSULE [QPHARMA INC]6Current NDC, Legacy NDC, 1 package rows20241123_e8b3ece4-cf73-416c-8767-68f425df35f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNe8b3ece4-cf73-416c-8767-68f425df35f87
309114cephalexin 500 MG Oral CapsuleSCDe8b3ece4-cf73-416c-8767-68f425df35f87
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYe8b3ece4-cf73-416c-8767-68f425df35f87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-017-284270800172828 CAPSULE in 1 BOTTLE (42708-017-28) 28 capsule2018-03-140000-00-00YesNoCurrent