NDC 16729-364

TIGECYCLINE

Tigecycline

TIGECYCLINE is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Tigecycline.

Product ID16729-364_8541a1ed-2a2c-1fab-e053-2a91aa0a29d1
NDC16729-364
Product TypeHuman Prescription Drug
Proprietary NameTIGECYCLINE
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-03-28
Marketing CategoryNDA / NDA
Application NumberNDA208744
Labeler NameAccord Healthcare Inc.
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/10mL
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-364-68

10 VIAL, SINGLE-DOSE in 1 CARTON (16729-364-68) > 10 mL in 1 VIAL, SINGLE-DOSE (16729-364-03)
Marketing Start Date2019-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-364-68 [16729036468]

TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA208744
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-28

NDC 16729-364-03 [16729036403]

TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA208744
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-28

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/10mL

OpenFDA Data

SPL SET ID:70bf7ad3-ebf9-4fea-b3ac-26c537736d3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 581531
  • UPC Code
  • 0316729364034
  • Pharmacological Class

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