NDC 70121-1647

Tigecycline

Tigecycline

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

Product ID70121-1647_40d436d3-8136-49e1-9a37-1878d4c07ed0
NDC70121-1647
Product TypeHuman Prescription Drug
Proprietary NameTigecycline
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-31
Marketing CategoryNDA / NDA
Application NumberNDA211158
Labeler NameAmneal Biosciences LLC
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/5mL
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70121-1647-7

10 VIAL in 1 CARTON (70121-1647-7) > 5 mL in 1 VIAL (70121-1647-1)
Marketing Start Date2018-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70121-1647-1 [70121164701]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA211158
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-31

NDC 70121-1647-7 [70121164707]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA211158
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-31

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/5mL

OpenFDA Data

SPL SET ID:8450bd15-2b06-4fc7-b302-9021312e3f0d
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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