Cephalexin

Product NDC
0143-9897
11-digit product format
001439897
Labeler code
0143
Product ID
0143-9897_05767850-451f-450d-91f1-e1fe9aa63626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065215
Marketing category
ANDA
Marketing start
2006-02-01
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
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9897-01EA - Each0143-9897b7bdc585-14d0-4753-b904-696e0b87c7d812012-07-24
0143-9897-05EA - Each0143-9897eae69713-8b50-47be-99e8-b945fb1ac53712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNeffe46a4-c383-4171-8ab4-2af9de316f083
309114cephalexin 500 MG Oral CapsuleSCDeffe46a4-c383-4171-8ab4-2af9de316f083
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYeffe46a4-c383-4171-8ab4-2af9de316f083
309112cephalexin 250 MG Oral CapsulePSN27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cephalexin 500 MG Oral CapsulePSN27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cephalexin 500 MG Oral CapsulePSN803cdf4c-77ec-4b9b-bc2d-873eb236f9c71
309114cephalexin 500 MG Oral CapsulePSN9ef147ae-fcc5-4fd1-b65c-7a37dae89b911
309112cephalexin 250 MG Oral CapsuleSCD27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cephalexin 500 MG Oral CapsuleSCD27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cephalexin 500 MG Oral CapsuleSCD803cdf4c-77ec-4b9b-bc2d-873eb236f9c71
309114cephalexin 500 MG Oral CapsuleSCD9ef147ae-fcc5-4fd1-b65c-7a37dae89b911
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY803cdf4c-77ec-4b9b-bc2d-873eb236f9c71
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY9ef147ae-fcc5-4fd1-b65c-7a37dae89b911
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY27f5aa5b-28ca-4154-b37e-18a931bf33981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9897-0100143989701100 CAPSULE in 1 BOTTLE, PLASTIC (0143-9897-01) 100 capsule2006-02-010000-00-00NoNoCurrent
0143-9897-0500143989705500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9897-05) 500 capsule2006-02-010000-00-00NoNoCurrent