NDC 55150-228

Tigecycline

Tigecycline

Tigecycline is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Tigecycline.

Product ID55150-228_345f1f30-3670-4a7d-ad5e-8eadda242d44
NDC55150-228
Product TypeHuman Prescription Drug
Proprietary NameTigecycline
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-11
Marketing CategoryANDA / ANDA
Application NumberANDA206335
Labeler NameAuroMedics Pharma LLC
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/1
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55150-228-10

10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-228-10 [55150022810]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206335
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-11

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/1

OpenFDA Data

SPL SET ID:dd58e0c3-d8a8-4cf2-96f8-9dd08f309579
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 581531
  • UPC Code
  • 0355150228102
  • Pharmacological Class

    • Tetracycline-class Antibacterial [EPC]
    • Tetracyclines [CS]

    NDC Crossover Matching brand name "Tigecycline" or generic name "Tigecycline"

    NDCBrand NameGeneric Name
    0781-3481TigecyclineTigecycline
    16729-364TIGECYCLINETIGECYCLINE
    55150-228TigecyclineTigecycline
    60505-6098TigecyclineTIGECYCLINE
    63323-960TigecyclineTigecycline
    70121-1647TigecyclineTigecycline
    70594-035TigecyclineTigecycline
    71288-019TigecyclineTigecycline
    0008-4990TygacilTIGECYCLINE
    0008-4994TygacilTIGECYCLINE

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