FDA.reportPublic FDA data

cephalexin

Product NDC
42043-140
11-digit product format
420430140
Labeler code
42043
Product ID
42043-140_517b57f4-c3b9-414c-bac5-59b1008f6c34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA065248
Marketing category
ANDA
Marketing start
2007-12-12
Marketing end
2020-08-31
Substance
CEPHALEXIN
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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
42043-140-01EA - Each42043-14083dcb261-2688-40c8-825d-c03591705cd512012-07-24
42043-140-05EA - Each42043-140dcd456f6-e0bd-412e-b002-bde891c577f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [STRATEGIC PHARMACEUTICAL SOLUTIONS, INC. DBA VETSOURCE]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNde8d97fd-3a76-4019-a640-882066c25c191
309114cephalexin 500 MG Oral CapsulePSNde8d97fd-3a76-4019-a640-882066c25c191
309112cephalexin 250 MG Oral CapsuleSCDde8d97fd-3a76-4019-a640-882066c25c191
309114cephalexin 500 MG Oral CapsuleSCDde8d97fd-3a76-4019-a640-882066c25c191
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYde8d97fd-3a76-4019-a640-882066c25c191
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYde8d97fd-3a76-4019-a640-882066c25c191