FDA.reportPublic FDA data

Cephalexin

Product NDC
68788-8538
11-digit product format
687888538
Labeler code
68788
Product ID
68788-8538_cabeccb5-a7a9-4906-90f5-70af57054fa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2023-10-19
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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
68788-8538-1Cephalexin12 in 1 BOTTLECAPSULE124
68788-8538-2Cephalexin20 in 1 BOTTLECAPSULE204
68788-8538-3Cephalexin30 in 1 BOTTLECAPSULE304
68788-8538-4Cephalexin40 in 1 BOTTLECAPSULE404
68788-8538-5Cephalexin6 in 1 BOTTLECAPSULE64
68788-8538-6Cephalexin60 in 1 BOTTLECAPSULE604
68788-8538-7Cephalexin21 in 1 BOTTLECAPSULE214
68788-8538-8Cephalexin28 in 1 BOTTLECAPSULE284
68788-8538-9Cephalexin14 in 1 BOTTLECAPSULE144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8538-1EA - Each68788-85381237de30-3f7e-4214-830e-175bc15e0d2512023-12-05
68788-8538-2EA - Each68788-8538112e5e0b-82e3-41b5-833e-ae78f96125db12023-12-05
68788-8538-3EA - Each68788-85381b0dfb80-0b41-420e-8747-8374e1f70c9b12023-12-05
68788-8538-4EA - Each68788-8538e830649f-f0e6-478d-b058-e7314d1fc38e12023-12-05
68788-8538-5EA - Each68788-85381cdbf78c-e01e-4868-9862-55332a810a4e12023-12-05
68788-8538-6EA - Each68788-85382b3074c7-6e62-4429-90fe-ba4cb5d4b6a112023-12-05
68788-8538-7EA - Each68788-85389b31f3aa-1ae9-4f9c-ab86-b99d79c813be12023-12-05
68788-8538-8EA - Each68788-85383edc8af2-02d9-487b-8484-af65db1a77dd12023-12-05
68788-8538-9EA - Each68788-8538f172f694-2eb2-47fd-b8b8-5263da56b14c12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8538CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 9 package rows20250223_52d8a080-eafc-46fe-82d9-6b69c6a3a38a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN52d8a080-eafc-46fe-82d9-6b69c6a3a38a4
309114cephalexin 500 MG Oral CapsuleSCD52d8a080-eafc-46fe-82d9-6b69c6a3a38a4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY52d8a080-eafc-46fe-82d9-6b69c6a3a38a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8538-16878885380112 CAPSULE in 1 BOTTLE (68788-8538-1) 12 capsule2023-10-19NoNoHistorical
68788-8538-26878885380220 CAPSULE in 1 BOTTLE (68788-8538-2) 20 capsule2023-10-19NoNoHistorical
68788-8538-36878885380330 CAPSULE in 1 BOTTLE (68788-8538-3) 30 capsule2023-10-19NoNoHistorical
68788-8538-46878885380440 CAPSULE in 1 BOTTLE (68788-8538-4) 40 capsule2023-10-19NoNoHistorical
68788-8538-5687888538056 CAPSULE in 1 BOTTLE (68788-8538-5) 6 capsule2023-10-19NoNoHistorical
68788-8538-66878885380660 CAPSULE in 1 BOTTLE (68788-8538-6) 60 capsule2023-10-19NoNoHistorical
68788-8538-76878885380721 CAPSULE in 1 BOTTLE (68788-8538-7) 21 capsule2023-10-19NoNoHistorical
68788-8538-86878885380828 CAPSULE in 1 BOTTLE (68788-8538-8) 28 capsule2023-10-19NoNoHistorical
68788-8538-96878885380914 CAPSULE in 1 BOTTLE (68788-8538-9) 14 capsule2023-10-19NoNoHistorical