FDA.reportPublic FDA data

Cefaclor

Product NDC
50090-1602
11-digit product format
500901602
Labeler code
50090
Product ID
50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefaclor
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065146
Marketing category
ANDA
Marketing start
2008-07-31
Substance
CEFACLOR
Active strength
500 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
CEFACLOR500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69K7K19H4L
Rxcui197449

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1602-02023-02-07C16284748780-1f386c64a-2736-0266-e053-dadaa90a7c1aCefaclor Capsules USP
50090-1602-22023-02-07C16284748780-1f386c64a-2736-0266-e053-dadaa90a7c1aCefaclor Capsules USP
50090-1602-02023-01-30C16284748780-1f386c64a-2736-0266-e053-dadaa90a7c1aCefaclor Capsules USP
50090-1602-22023-01-30C16284748780-1f386c64a-2736-0266-e053-dadaa90a7c1aCefaclor Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1602-0Cefaclor30 in 1 BOTTLECAPSULE3010
50090-1602-2Cefaclor21 in 1 BOTTLECAPSULE2110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1602-0EA - Each50090-16021a99ee91-7cf0-448e-aa01-7cc1b4b5380312021-09-07
50090-1602-2EA - Each50090-160250a62d4b-a673-4971-84c2-cc93906e184512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1602CEFACLOR CAPSULE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240201_d79a4b28-ef2b-4f0f-baec-002df7d06dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197449cefaclor 500 MG Oral CapsulePSNd79a4b28-ef2b-4f0f-baec-002df7d06dd410
197449cefaclor 500 MG Oral CapsuleSCDd79a4b28-ef2b-4f0f-baec-002df7d06dd410
197449cefaclor (as cefaclor monohydrate) 500 MG Oral CapsuleSYd79a4b28-ef2b-4f0f-baec-002df7d06dd410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1602-05009016020030 CAPSULE in 1 BOTTLE (50090-1602-0) 30 capsule2019-02-200000-00-00NoNoCurrent
50090-1602-25009016020221 CAPSULE in 1 BOTTLE (50090-1602-2) 21 capsule2015-01-060000-00-00NoNoCurrent