Cefaclor

Product NDC
81948-6250
11-digit product format
819486250
Labeler code
81948
Product ID
81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefaclor
Dosage form
SUSPENSION
Route
ORAL
Labeler
Azorian Pharma, LLC
Application
ANDA065412
Marketing category
ANDA
Marketing start
2022-11-01
Substance
CEFACLOR
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
Cefaclor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFACLOR250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69K7K19H4L
Rxcui313888

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57d340b5-4768-6bd5-e047-9a70a6cc1ce7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81948-6250-1Cefaclor150 mL in 1 BOTTLESUSPENSION1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81948-6250-1ML - Milliliter81948-62508a3f4f12-1108-496e-9710-91c9089d837d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81948-6250CEFACLOR SUSPENSION [AZORIAN PHARMA, LLC]1Current NDC, Legacy NDC, 1 package rows20221109_224af904-38f3-4210-a750-e21006db4c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313888cefaclor 250 MG in 5 mL Oral SuspensionPSN224af904-38f3-4210-a750-e21006db4c661
313888cefaclor 50 MG/ML Oral SuspensionSCD224af904-38f3-4210-a750-e21006db4c661
313888cefaclor (as cefaclor monohydrate) 50 MG/ML Oral SuspensionSY224af904-38f3-4210-a750-e21006db4c661
313888cefaclor 250 MG per 5 ML Oral SuspensionSY224af904-38f3-4210-a750-e21006db4c661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81948-6250-181948625001150 mL in 1 BOTTLE (81948-6250-1) 150 ml2022-11-010000-00-00NoNoCurrent