FDA.reportPublic FDA data

Cephalexin

Product NDC
66267-982
11-digit product format
662670982
Labeler code
66267
Product ID
66267-982_1fa7ce69-a972-59e7-e063-6394a90af771
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062703
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CEPHALEXIN
Active strength
250 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309113

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
66267-982-002024-08-14C16284748780-1f386c649-f307-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971
66267-982-002023-01-30C16284748780-1f386c649-f307-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-982-00Cephalexin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-982-00ML - Milliliter66267-98214b4dc7b-6039-4791-9760-20d1e032765e12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-982CEPHALEXIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240816_549bf887-1ef6-6a75-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN549bf887-1ef6-6a75-e054-00144ff8d46c5
309113cephalexin 50 MG/ML Oral SuspensionSCD549bf887-1ef6-6a75-e054-00144ff8d46c5
309113cefalexin 50 MG/ML Oral SuspensionSY549bf887-1ef6-6a75-e054-00144ff8d46c5
309113cephalexin 250 MG per 5 ML Oral SuspensionSY549bf887-1ef6-6a75-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-982-0066267098200100 mL in 1 BOTTLE (66267-982-00) 100 ml2017-07-180000-00-00NoNoCurrent