NDC 68289-008

Cephalexin USP

Cephalexin

Cephalexin USP is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Jazeera Pharmaceutical. The primary component is Cephalexin Anhydrous.

Product ID68289-008_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8
NDC68289-008
Product TypeHuman Prescription Drug
Proprietary NameCephalexin USP
Generic NameCephalexin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2009-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA065444
Labeler NameJazeera Pharmaceutical
Substance NameCEPHALEXIN ANHYDROUS
Active Ingredient Strength125 mg/5mL
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68289-008-01

100 mL in 1 BOTTLE (68289-008-01)
Marketing Start Date2009-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68289-008-01 [68289000801]

Cephalexin USP SUSPENSION
Marketing CategoryANDA
Application NumberANDA065444
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-10-21

NDC 68289-008-20 [68289000820]

Cephalexin USP SUSPENSION
Marketing CategoryANDA
Application NumberANDA065444
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
CEPHALEXIN ANHYDROUS125 mg/5mL

OpenFDA Data

SPL SET ID:2b388b1e-cd59-42de-ba72-858485b070b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309113
  • 309110
  • UPC Code
  • 0368289008200
  • 0368289008019
  • 0368289009207
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cephalexin USP" or generic name "Cephalexin"

    NDCBrand NameGeneric Name
    68289-008Cephalexin USPCephalexin USP
    68289-009Cephalexin USPCephalexin USP
    0093-2238CephalexinCephalexin
    0093-2240CephalexinCephalexin
    0093-3145CephalexinCephalexin
    0093-3147CephalexinCephalexin
    0093-4175CephalexinCephalexin
    0093-4177CephalexinCephalexin
    0143-9769CephalexinCephalexin
    0143-9770CephalexinCephalexin
    0143-9897CephalexinCephalexin
    0143-9898CephalexinCephalexin

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