Cephalexin

Product NDC
0904-7337
11-digit product format
009047337
Labeler code
0904
Product ID
0904-7337_1c1fbad7-bef4-42a0-a8c9-b35168f5d533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090836
Marketing category
ANDA
Marketing start
2023-11-06
Substance
CEPHALEXIN
Active strength
500 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
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112, 309114

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
0904-7337-06Cephalexin50 in 1 CARTONCAPSULE501
0904-7337-06Cephalexin1 in 1 BLISTER PACKCAPSULE11
0904-7337-61Cephalexin1 in 1 BLISTER PACKCAPSULE11
0904-7337-61Cephalexin100 in 1 CARTONCAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7337-06EA - Each0904-733767b35870-f4fb-4a6b-b732-c1b1e116a0df12023-12-05
0904-7337-61EA - Each0904-7337b25f9a52-51a1-4966-b4dc-feb05a7c8a4712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7337CEPHALEXIN CAPSULE [MAJOR PHARMACEUTICALS]1Current NDC, 4 package rows20231110_1c1fbad7-bef4-42a0-a8c9-b35168f5d533.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309114cephalexin 500 MG Oral CapsulePSN1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309112cephalexin 250 MG Oral CapsuleSCD1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309114cephalexin 500 MG Oral CapsuleSCD1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1c1fbad7-bef4-42a0-a8c9-b35168f5d5331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7337-060090473370650 BLISTER PACK in 1 CARTON (0904-7337-06) / 1 CAPSULE in 1 BLISTER PACK50 blister pack2023-11-06NoNoHistorical
0904-7337-6100904733761100 BLISTER PACK in 1 CARTON (0904-7337-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2023-11-06NoNoHistorical