cephalexin

Product NDC
33261-149
11-digit product format
332610149
Labeler code
33261
Product ID
33261-149_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062791
Marketing category
ANDA
Marketing start
2010-06-21
Marketing end
0000-00-00
Substance
CEPHALEXIN ANHYDROUS
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-149-002020-01-31C16284748780-19d75b9d0-8842-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
33261-149-202020-01-31C16284748780-19d75b9d0-8842-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
33261-149-282020-01-31C16284748780-19d75b9d0-8842-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
33261-149-302020-01-31C16284748780-19d75b9d0-8842-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
33261-149-402020-01-31C16284748780-19d75b9d0-8842-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-149-00cephalexin100 in 1 BOTTLECAPSULE1003
33261-149-20cephalexin20 in 1 BOTTLECAPSULE203
33261-149-28cephalexin28 in 1 BOTTLECAPSULE283
33261-149-30cephalexin30 in 1 BOTTLECAPSULE303
33261-149-40cephalexin40 in 1 BOTTLECAPSULE403

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXIN ANHYDROUSACTIVE INGREDIENT5SFF1W6677CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-149CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 5 package rows20120914_cab0d668-f4a4-4848-ba93-fa2c2246096c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNcab0d668-f4a4-4848-ba93-fa2c2246096c3
309114cephalexin 500 MG Oral CapsulePSNcab0d668-f4a4-4848-ba93-fa2c2246096c3
309112cephalexin 250 MG Oral CapsuleSCDcab0d668-f4a4-4848-ba93-fa2c2246096c3
309114cephalexin 500 MG Oral CapsuleSCDcab0d668-f4a4-4848-ba93-fa2c2246096c3
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYcab0d668-f4a4-4848-ba93-fa2c2246096c3
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYcab0d668-f4a4-4848-ba93-fa2c2246096c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-149-0033261014900100 in 1 BOTTLEHistorical
33261-149-203326101492020 in 1 BOTTLEHistorical
33261-149-283326101492828 in 1 BOTTLEHistorical
33261-149-303326101493030 in 1 BOTTLEHistorical
33261-149-403326101494040 in 1 BOTTLEHistorical