NDC 0049-0014

UNASYN

Ampicillin Sodium And Sulbactam Sodium

UNASYN is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Ampicillin Sodium; Sulbactam Sodium.

Product ID0049-0014_1d9ff1e7-9cb0-45d9-92af-ad3c6b94da1c
NDC0049-0014
Product TypeHuman Prescription Drug
Proprietary NameUNASYN
Generic NameAmpicillin Sodium And Sulbactam Sodium
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1991-11-22
Marketing CategoryNDA / NDA
Application NumberNDA050608
Labeler NameRoerig
Substance NameAMPICILLIN SODIUM; SULBACTAM SODIUM
Active Ingredient Strength2 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 0049-0014-83

10 VIAL in 1 CARTON (0049-0014-83) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)
Marketing Start Date1991-11-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0049-0014-83 [00049001483]

UNASYN INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-11-22

NDC 0049-0014-81 [00049001481]

UNASYN INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-05

Drug Details

Active Ingredients

IngredientStrength
AMPICILLIN SODIUM2 g/1

OpenFDA Data

SPL SET ID:155c7ec0-5862-404f-b1d0-f278f8a8bbda
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659595
  • 1659598
  • 1659600
  • 1659592

    • Pharmacological Class

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

    NDC Crossover Matching brand name "UNASYN" or generic name "Ampicillin Sodium And Sulbactam Sodium"

    NDCBrand NameGeneric Name
    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
    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

    Trademark Results [UNASYN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    UNASYN
    UNASYN
    72243575 0818579 Live/Registered
    CHAS. PFIZER & CO., INC.
    1966-04-15
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.