Cefaclor

Product NDC
0093-1087
11-digit product format
000931087
Labeler code
0093
Product ID
0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefaclor
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065058
Marketing category
ANDA
Marketing start
2002-09-26
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
Rxcui309043

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
57d340b5-4768-6bd5-e047-9a70a6cc1ce7Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-1087-01Cefaclor100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1087-01EA - Each0093-10877335c3e6-1e74-4351-9fc7-63dcd788a45812012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1087CEFACLOR TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 1 package rows20210520_0878bdc2-0410-4938-9890-96523aa81c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309043cefaclor 500 MG 12HR Extended Release Oral TabletPSN0878bdc2-0410-4938-9890-96523aa81c2f11
30904312 HR cefaclor 500 MG Extended Release Oral TabletSCD0878bdc2-0410-4938-9890-96523aa81c2f11
309043cefaclor 500 MG 12 HR Extended Release Oral TabletSY0878bdc2-0410-4938-9890-96523aa81c2f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-1087-0100093108701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01) 2002-09-260000-00-00NoNoCurrent