FDA.reportPublic FDA data

Cefaclor

Product NDC
61442-171
11-digit product format
614420171
Labeler code
61442
Product ID
61442-171_3417e20b-604b-3cdd-e063-6394a90ac707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefaclor
Dosage form
CAPSULE
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA065146
Marketing category
ANDA
Marketing start
2008-07-31
Substance
CEFACLOR
Active strength
250 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
Cefaclor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFACLOR250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69K7K19H4L
Rxcui197449, 309045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
57d340b5-4768-6bd5-e047-9a70a6cc1ce7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61442-171-01Cefaclor100 in 1 BOTTLE, PLASTICCAPSULE1004
61442-171-05Cefaclor500 in 1 BOTTLE, PLASTICCAPSULE5004
61442-171-30Cefaclor30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-171-30EA - Each61442-17152c0f305-a48a-4433-afe8-97fa6db2ff1b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFACLORACTIVE INGREDIENT69K7K19H4LCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
CEFACLOR ANHYDROUSACTIVE MOIETY3Z6FS3IK0KCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
ammoniaINACTIVE INGREDIENT5138Q19F1XCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
shellacINACTIVE INGREDIENT46N107B71OCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
tert-butyl alcoholINACTIVE INGREDIENTMD83SFE959CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-171CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]4Current NDC, Legacy NDC, 3 package rows20250503_2f61354e-bcb0-41aa-955f-51eabc11387b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309045cefaclor 250 MG Oral CapsulePSN2f61354e-bcb0-41aa-955f-51eabc11387b4
197449cefaclor 500 MG Oral CapsulePSN2f61354e-bcb0-41aa-955f-51eabc11387b4
309045cefaclor 250 MG Oral CapsuleSCD2f61354e-bcb0-41aa-955f-51eabc11387b4
197449cefaclor 500 MG Oral CapsuleSCD2f61354e-bcb0-41aa-955f-51eabc11387b4
309045cefaclor (as cefaclor monohydrate) 250 MG Oral CapsuleSY2f61354e-bcb0-41aa-955f-51eabc11387b4
197449cefaclor (as cefaclor monohydrate) 500 MG Oral CapsuleSY2f61354e-bcb0-41aa-955f-51eabc11387b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61442-171-0161442017101100 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-01) 100 capsule2008-07-310000-00-00NoNoCurrent
61442-171-0561442017105500 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-05) 500 capsule2008-07-310000-00-00NoNoCurrent
61442-171-306144201713030 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-30) 30 capsule2008-07-310000-00-00NoNoCurrent