FDA.reportPublic FDA data

Cephalexin

Product NDC
50268-151
11-digit product format
502680151
Labeler code
50268
Product ID
50268-151_426b7e9a-a0f9-c61c-e063-6294a90a0b98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA090836
Marketing category
ANDA
Marketing start
2014-09-15
Substance
CEPHALEXIN
Active strength
250 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
CEPHALEXIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112, 309114

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-151-11Cephalexin1 in 1 BLISTER PACKCAPSULE19
50268-151-15Cephalexin50 in 1 BOXCAPSULE509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-151-11EA - Each50268-1516ffeabce-2f68-42a8-a0ef-67843006615d12014-12-01
50268-151-15EA - Each50268-1511285cc2d-dbb9-4072-84a5-2aa26466e05012014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [AVPAK]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [AVPAK]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [AVPAK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [AVPAK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [AVPAK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [AVPAK]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [AVPAK]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [AVPAK]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [AVPAK]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [AVPAK]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [AVPAK]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [AVPAK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-151CEPHALEXIN CAPSULE [AVPAK]8Current NDC, Legacy NDC, 2 package rows20240110_5975f293-8bb3-3242-aca7-d7d0c7e1bdc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN5975f293-8bb3-3242-aca7-d7d0c7e1bdc89
309114cephalexin 500 MG Oral CapsulePSN5975f293-8bb3-3242-aca7-d7d0c7e1bdc89
309112cephalexin 250 MG Oral CapsuleSCD5975f293-8bb3-3242-aca7-d7d0c7e1bdc89
309114cephalexin 500 MG Oral CapsuleSCD5975f293-8bb3-3242-aca7-d7d0c7e1bdc89
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY5975f293-8bb3-3242-aca7-d7d0c7e1bdc89
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY5975f293-8bb3-3242-aca7-d7d0c7e1bdc89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-151-11502680151111 in 1 BLISTER PACKHistorical
50268-151-155026801511550 BLISTER PACK in 1 BOX (50268-151-15) / 1 CAPSULE in 1 BLISTER PACK (50268-151-11) 50 blister pack2014-09-150000-00-00NoNoCurrent