NDC 59115-071

CEFACLOR

Cefaclor

CEFACLOR is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceutical. The primary component is Cefaclor.

Product ID59115-071_1ba7db86-11d0-4eb5-a4a1-96d7bf17523f
NDC59115-071
Product TypeHuman Prescription Drug
Proprietary NameCEFACLOR
Generic NameCefaclor
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-07-07
Marketing CategoryANDA / ANDA
Application NumberANDA065350
Labeler NameHikma Pharmaceutical
Substance NameCEFACLOR
Active Ingredient Strength500 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59115-071-15

15 CAPSULE in 1 BOTTLE (59115-071-15)
Marketing Start Date2015-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59115-071-01 [59115007101]

CEFACLOR CAPSULE
Marketing CategoryANDA
Application NumberANDA065350
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-07

NDC 59115-071-15 [59115007115]

CEFACLOR CAPSULE
Marketing CategoryANDA
Application NumberANDA065350
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-07

Drug Details

Active Ingredients

IngredientStrength
CEFACLOR500 mg/1

OpenFDA Data

SPL SET ID:78752b32-6295-4e27-ad4c-7723c433930d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309045
  • 197449
  • UPC Code
  • 0359115072014
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]
    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "CEFACLOR" or generic name "Cefaclor"

    NDCBrand NameGeneric Name
    0093-1087CefaclorCefaclor
    0143-9985CEFACLORCEFACLOR
    0143-9986CEFACLORCEFACLOR
    16571-070CefaclorCefaclor
    16571-071CefaclorCefaclor
    16571-072CefaclorCefaclor
    21695-782CEFACLORCEFACLOR
    23594-125Cefaclorcefaclor
    23594-250Cefaclorcefaclor
    23594-375Cefaclorcefaclor
    43063-194CEFACLORCEFACLOR
    50090-0518CEFACLORCEFACLOR
    50090-1602CefaclorCefaclor
    59115-071CEFACLORCEFACLOR
    59115-072CEFACLORCEFACLOR
    61442-171CefaclorCefaclor
    61442-172CefaclorCefaclor
    61442-173CefaclorCefaclor
    61442-174CefaclorCefaclor
    61442-175CefaclorCefaclor
    61442-176CefaclorCefaclor
    63629-1007CefaclorCefaclor
    68289-003Cefaclorcefaclor
    68289-004Cefaclorcefaclor
    81948-6250Cefaclorcefaclor

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