Cephalexin

Product NDC
43063-678
11-digit product format
430630678
Labeler code
43063
Product ID
43063-678_413a0525-f147-a7a9-e063-6394a90ad8dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-20
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

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
43063-678-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2832
43063-678-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-678CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 2 package rows20240314_e4e1ebcf-b43b-4dbe-9295-eeef67ba6272.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNe4e1ebcf-b43b-4dbe-9295-eeef67ba627232
309112cephalexin 250 MG Oral CapsuleSCDe4e1ebcf-b43b-4dbe-9295-eeef67ba627232
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYe4e1ebcf-b43b-4dbe-9295-eeef67ba627232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-678-284306306782828 CAPSULE in 1 BOTTLE, PLASTIC (43063-678-28) 28 capsule2024-03-12NoNoCurrent
43063-678-404306306784040 CAPSULE in 1 BOTTLE, PLASTIC (43063-678-40) 40 capsule2016-06-130000-00-00NoNoCurrent