NDC 67457-348

ampicillin sodium and sulbactam sodium

Ampicillin Sodium And Sulbactam Sodium

ampicillin sodium and sulbactam sodium is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Ampicillin Sodium; Sulbactam Sodium.

Product ID67457-348_421fed92-b5ee-4802-9703-3e269510bcfe
NDC67457-348
Product TypeHuman Prescription Drug
Proprietary Nameampicillin sodium and sulbactam sodium
Generic NameAmpicillin Sodium And Sulbactam Sodium
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2014-04-08
Marketing CategoryANDA / ANDA
Application NumberANDA201024
Labeler NameMylan Institutional LLC
Substance NameAMPICILLIN SODIUM; SULBACTAM SODIUM
Active Ingredient Strength1 g/1; g/1
Pharm ClassesPenicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 67457-348-10

10 VIAL in 1 CARTON (67457-348-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Marketing Start Date2017-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-348-10 [67457034810]

ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA201024
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-01

NDC 67457-348-15 [67457034815]

ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA201024
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-04
Marketing End Date2018-03-31

Drug Details

Active Ingredients

IngredientStrength
AMPICILLIN SODIUM1 g/1

OpenFDA Data

SPL SET ID:7ed253b5-fcec-4518-bd74-b831064c5489
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659598
  • 1659592
  • Pharmacological Class

    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]
    • beta Lactamase Inhibitor [EPC]
    • beta Lactamase Inhibitors [MoA]
    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]
    • beta Lactamase Inhibitor [EPC]
    • beta Lactamase Inhibitors [MoA]

    NDC Crossover Matching brand name "ampicillin sodium and sulbactam sodium" or generic name "Ampicillin Sodium And Sulbactam Sodium"

    NDCBrand NameGeneric Name
    67457-649ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodium
    67457-348ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodium
    67457-349ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodium
    0409-2689Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0409-2987Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0781-3032Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0781-3033Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0781-3034Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    25021-186ampicillin and sulbactamampicillin sodium and sulbactam sodium
    25021-187ampicillin and sulbactamampicillin sodium and sulbactam sodium
    25021-188ampicillin and sulbactamampicillin sodium and sulbactam sodium
    36000-094Ampicillin and SulbactamAmpicillin sodium and sulbactam sodium
    36000-095Ampicillin and SulbactamAmpicillin sodium and sulbactam sodium
    43858-133Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    43858-134Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    55150-116Ampicillin and SulbactamAmpicillin Sodium and Sulbactam Sodium
    0049-0013UNASYNampicillin sodium and sulbactam sodium
    0049-0014UNASYNampicillin sodium and sulbactam sodium
    0049-0022UNASYNampicillin sodium and sulbactam sodium
    0049-0023UNASYNampicillin sodium and sulbactam sodium
    0049-0024UNASYNampicillin sodium and sulbactam sodium

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