FDA.reportPublic FDA data

CEFACLOR

Product NDC
0143-9985
Requested package NDC
0143-9985-01
11-digit product format
001439985
Labeler code
0143
Product ID
0143-9985_79869725-288c-4691-a0d3-8d02b7caf510
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFACLOR
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065350
Marketing category
ANDA
Marketing start
2007-05-01
Marketing end
0000-00-00
Substance
CEFACLOR
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0143-99850143-9985-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065350-001CEFACLOREQ 250MG BASECAPSULE / ORAL2007-04-03a50c72e98297…
2026-08-01 22:54:322026-06A065350-002CEFACLOREQ 500MG BASECAPSULE / ORAL2007-04-03a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9985-01EA - Each0143-9985a9767096-99cb-4cee-b982-3569a9c9a08c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFACLORACTIVE INGREDIENT69K7K19H4LCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
CEFACLOR ANHYDROUSACTIVE MOIETY3Z6FS3IK0KCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
GELATININACTIVE INGREDIENT2G86QN327LCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9985-0100143998501100 CAPSULE in 1 BOTTLE (0143-9985-01) 100 capsule2007-05-010000-00-00NoNoCurrent