NDC 68289-003

Cefaclor

Cefaclor

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

Product ID68289-003_2350d1e3-187a-4cb7-94f5-0c66d7e651f9
NDC68289-003
Product TypeHuman Prescription Drug
Proprietary NameCefaclor
Generic NameCefaclor
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA065350
Labeler NameJazeera Pharmaceutical
Substance NameCEFACLOR
Active Ingredient Strength500 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68289-003-01

100 CAPSULE in 1 BOTTLE (68289-003-01)
Marketing Start Date2007-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68289-003-15 [68289000315]

Cefaclor CAPSULE
Marketing CategoryANDA
Application NumberANDA065350
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-04

NDC 68289-003-01 [68289000301]

Cefaclor CAPSULE
Marketing CategoryANDA
Application NumberANDA065350
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-04

Drug Details

Active Ingredients

IngredientStrength
CEFACLOR500 mg/1

OpenFDA Data

SPL SET ID:a6da2a47-cbea-4669-9451-4b507959378c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309045
  • 197449
  • 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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