NDC 71288-005

Ampicillin and Sulbactam

Ampicillin Sodium And Sulbactam Sodium

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

Product ID71288-005_0478d88f-efdc-479a-bd7d-b1f49e5de1e2
NDC71288-005
Product TypeHuman Prescription Drug
Proprietary NameAmpicillin and Sulbactam
Generic NameAmpicillin Sodium And Sulbactam Sodium
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2022-01-17
Marketing CategoryANDA / ANDA
Application NumberANDA090579
Labeler NameMeitheal Pharmaceuticals Inc.
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 Through2023-12-31

Packaging

NDC 71288-005-20

10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
Marketing Start Date2022-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-005-21 [71288000521]

Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-23

NDC 71288-005-20 [71288000520]

Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
AMPICILLIN SODIUM1 g/1

OpenFDA Data

SPL SET ID:6ae2c4a1-f704-4642-bbdd-f69a9ef07605
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]

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

    NDCBrand NameGeneric Name
    0409-2689Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0409-2987Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0641-6116Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6117Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6118Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6119Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6120Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6121Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6122Ampicillin and SulbactamAmpicillin and Sulbactam
    0641-6123Ampicillin and SulbactamAmpicillin and Sulbactam
    0781-3032Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    0781-3033Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodium
    71288-005Ampicillin and SulbactamAmpicillin and Sulbactam
    71288-006Ampicillin and SulbactamAmpicillin and Sulbactam
    71288-007Ampicillin and SulbactamAmpicillin and Sulbactam
    0781-3034Ampicillin and SulbactamAmpicillin and Sulbactam
    25021-186ampicillin and sulbactamampicillin and sulbactam
    25021-142ampicillin and sulbactamampicillin and sulbactam
    25021-188ampicillin and sulbactamampicillin and sulbactam
    25021-144ampicillin and sulbactamampicillin and sulbactam
    25021-143ampicillin and sulbactamampicillin and sulbactam
    25021-187ampicillin and sulbactamampicillin and sulbactam
    36000-095Ampicillin and SulbactamAmpicillin and Sulbactam
    36000-094Ampicillin and SulbactamAmpicillin and Sulbactam
    44567-212Ampicillin and SulbactamAmpicillin and Sulbactam
    44567-210Ampicillin and SulbactamAmpicillin and Sulbactam
    44567-211Ampicillin and SulbactamAmpicillin and Sulbactam
    55150-117Ampicillin and SulbactamAmpicillin and Sulbactam
    55150-178Ampicillin and SulbactamAmpicillin and Sulbactam
    55150-179Ampicillin and SulbactamAmpicillin and Sulbactam
    55150-116Ampicillin and SulbactamAmpicillin and Sulbactam
    55150-118Ampicillin and SulbactamAmpicillin and Sulbactam
    63323-370Ampicillin and SulbactamAmpicillin and Sulbactam
    63323-368Ampicillin and SulbactamAmpicillin and Sulbactam
    63323-369Ampicillin and SulbactamAmpicillin and Sulbactam
    66794-208ampicillin and sulbactamampicillin and sulbactam
    66794-207ampicillin and sulbactamampicillin and sulbactam
    66794-206ampicillin and sulbactamampicillin and sulbactam
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.