NDC 0049-0420

Pfizerpen

Penicillin G Potassium

Pfizerpen is a Intramuscular; Intrapleural; Intrathecal; Intravenous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Penicillin G Potassium.

Product ID0049-0420_0af9125f-acc5-4852-a366-a5c5c36cac96
NDC0049-0420
Product TypeHuman Prescription Drug
Proprietary NamePfizerpen
Generic NamePenicillin G Potassium
Dosage FormPowder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS
Marketing Start Date2010-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA060657
Labeler NameRoerig
Substance NamePENICILLIN G POTASSIUM
Active Ingredient Strength5000000 [iU]/1
Pharm ClassesPenicillin-class Antibacterial [EPC], Penicillins [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0049-0420-10

10 VIAL in 1 CARTON (0049-0420-10) > 1 POWDER, FOR SOLUTION in 1 VIAL (0049-0420-05)
Marketing Start Date2018-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0049-0420-10 [00049042010]

Pfizerpen POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA060657
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-30

NDC 0049-0420-05 [00049042005]

Pfizerpen POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA060657
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-01

Drug Details

Active Ingredients

IngredientStrength
PENICILLIN G POTASSIUM5000000 [iU]/1

OpenFDA Data

SPL SET ID:2f7ea103-56cc-492f-b862-af45f9aed980
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995906
  • 863538
  • Pharmacological Class

    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]

    NDC Crossover Matching brand name "Pfizerpen" or generic name "Penicillin G Potassium"

    NDCBrand NameGeneric Name
    0049-0420Pfizerpenpenicillin G potassium
    0049-0430Pfizerpenpenicillin G potassium
    0049-0520Pfizerpenpenicillin G potassium
    0049-0530Pfizerpenpenicillin G potassium
    0781-6135Penicillin G PotassiumPenicillin G Potassium
    0781-6136Penicillin G PotassiumPenicillin G Potassium
    44567-310Penicillin G PotassiumPenicillin G Potassium
    44567-311Penicillin G PotassiumPenicillin G Potassium
    44567-312Penicillin G PotassiumPenicillin G Potassium
    70860-126Penicillin G Potassiumpenicillin g potassium
    70860-127Penicillin G Potassiumpenicillin g potassium

    Trademark Results [Pfizerpen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PFIZERPEN
    PFIZERPEN
    71694089 0629419 Live/Registered
    CHAS. PFIZER & CO., INC.
    1955-09-01

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.