FDA.reportPublic FDA data

CEFACLOR

Product NDC
59115-071
11-digit product format
591150071
Labeler code
59115
Product ID
59115-071_1ba7db86-11d0-4eb5-a4a1-96d7bf17523f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFACLOR
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceutical
Application
ANDA065350
Marketing category
ANDA
Marketing start
2015-07-07
Marketing end
0000-00-00
Substance
CEFACLOR
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59115-071DDiscontinued by firm2026-07-31
excluded packagepackage59115-07159115-071-01DDiscontinued by firm2026-07-31
excluded packagepackage59115-07159115-071-15DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065350-001CEFACLORCEFACLOREQ 250MG BASECAPSULE / ORAL2007-04-03
A065350-002CEFACLORCEFACLOREQ 500MG BASECAPSULE / ORAL2007-04-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59115-071-012023-12-05C16284748780-1ba0f9c33-1377-a910-e053-dadaa90a0b85CEFACLOR CAPSULES, USP Rev. 07/15 Rx Only
59115-071-152023-12-05C16284748780-1ba0f9c33-1377-a910-e053-dadaa90a0b85CEFACLOR CAPSULES, USP Rev. 07/15 Rx Only
59115-071-012021-01-29C16284748780-1ba0f9c33-1377-a910-e053-dadaa90a0b85CEFACLOR CAPSULES, USP Rev. 07/15 Rx Only
59115-071-152021-01-29C16284748780-1ba0f9c33-1377-a910-e053-dadaa90a0b85CEFACLOR CAPSULES, USP Rev. 07/15 Rx Only