NDC 70594-035

Tigecycline

Tigecycline

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

Product ID70594-035_996993f9-86d3-4bd1-a92e-d6b19643e6bd
NDC70594-035
Product TypeHuman Prescription Drug
Proprietary NameTigecycline
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA205722
Labeler NameXellia Pharmaceuticals USA LLC
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/1
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70594-035-02

10 VIAL, GLASS in 1 CARTON (70594-035-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-035-01)
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70594-035-01 [70594003501]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA205722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

NDC 70594-035-02 [70594003502]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA205722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/1

OpenFDA Data

SPL SET ID:4183ef14-7db7-4fe3-978b-a35b1d29f378
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 581531
  • 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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