FDA.reportPublic FDA data

Cefaclor

Product NDC
61442-174
11-digit product format
614420174
Labeler code
61442
Product ID
61442-174_2632c343-21cc-4563-96b3-ac1f0c78dae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefaclor
Dosage form
SUSPENSION
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA065412
Marketing category
ANDA
Marketing start
2012-03-27
Marketing end
0000-00-00
Substance
CEFACLOR
Active strength
187 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61442-174-012020-01-31C16284748780-19d75b9d0-4ef4-f424-e053-dadaa90a57ce9f919252-7a87-4386-a64c-5d8213f7e881
61442-174-022020-01-31C16284748780-19d75b9d0-4ef4-f424-e053-dadaa90a57ce9f919252-7a87-4386-a64c-5d8213f7e881

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CefaclorACTIVE INGREDIENT69K7K19H4LCEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
Cefaclor AnhydrousACTIVE MOIETY3Z6FS3IK0KCEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
METHYLCELLULOSE (25 CPS)INACTIVE INGREDIENTBI55GG2WLICEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
sucroseINACTIVE INGREDIENTC151H8M554CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEECEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-174CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3Legacy NDC20151021_9f919252-7a87-4386-a64c-5d8213f7e881.zip