NDC 43063-194

CEFACLOR

Cefaclor

CEFACLOR is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Cefaclor.

Product ID43063-194_7cc49c7e-4408-39f7-e053-2a91aa0aab5c
NDC43063-194
Product TypeHuman Prescription Drug
Proprietary NameCEFACLOR
Generic NameCefaclor
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA065350
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameCEFACLOR
Active Ingredient Strength500 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43063-194-30

30 CAPSULE in 1 BOTTLE, PLASTIC (43063-194-30)
Marketing Start Date2009-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-194-30 [43063019430]

CEFACLOR CAPSULE
Marketing CategoryANDA
Application NumberANDA065350
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-09-28
Marketing End Date2019-09-20

Drug Details

Active Ingredients

IngredientStrength
CEFACLOR500 mg/1

OpenFDA Data

SPL SET ID:b093ec49-da83-40e3-8e1c-8a64b7f45d27
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197449
  • UPC Code
  • 0343063194300
  • Pharmacological Class

    • 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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