cephalexin

Product NDC
68788-9752
11-digit product format
687889752
Labeler code
68788
Product ID
68788-9752_a35fc563-9bf1-4242-92f8-638c6827eba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA062791
Marketing category
ANDA
Marketing start
2010-06-21
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68788-9752-12020-01-31C16284748780-19d75b9d1-14f4-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.
68788-9752-22020-01-31C16284748780-19d75b9d1-14f4-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.
68788-9752-32020-01-31C16284748780-19d75b9d1-14f4-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.
68788-9752-42020-01-31C16284748780-19d75b9d1-14f4-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.
68788-9752-62020-01-31C16284748780-19d75b9d1-14f4-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.
68788-9752-72020-01-31C16284748780-19d75b9d1-14f4-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.
68788-9752-82020-01-31C16284748780-19d75b9d1-14f4-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
68788-9752-1cephalexin12 in 1 BOTTLECAPSULE123
68788-9752-2cephalexin20 in 1 BOTTLECAPSULE203
68788-9752-3cephalexin30 in 1 BOTTLECAPSULE303
68788-9752-4cephalexin40 in 1 BOTTLECAPSULE403
68788-9752-6cephalexin60 in 1 BOTTLECAPSULE603
68788-9752-7cephalexin21 in 1 BOTTLECAPSULE213
68788-9752-8cephalexin28 in 1 BOTTLECAPSULE283

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9752CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Legacy NDC, 7 package rows20141008_981e3b45-0fd0-4198-a6e0-fead314c85a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN981e3b45-0fd0-4198-a6e0-fead314c85a93
309114cephalexin 500 MG Oral CapsuleSCD981e3b45-0fd0-4198-a6e0-fead314c85a93
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY981e3b45-0fd0-4198-a6e0-fead314c85a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9752-16878897520112 in 1 BOTTLEHistorical
68788-9752-26878897520220 in 1 BOTTLEHistorical
68788-9752-36878897520330 in 1 BOTTLEHistorical
68788-9752-46878897520440 in 1 BOTTLEHistorical
68788-9752-66878897520660 in 1 BOTTLEHistorical
68788-9752-76878897520721 in 1 BOTTLEHistorical
68788-9752-86878897520828 in 1 BOTTLEHistorical