NDC 0781-3481

Tigecycline

Tigecycline

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

Product ID0781-3481_2e914e02-5c4f-401c-8fd6-82db93da5926
NDC0781-3481
Product TypeHuman Prescription Drug
Proprietary NameTigecycline
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS; PARENTERAL
Marketing Start Date2017-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA091620
Labeler NameSandoz Inc
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/10mL
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-3481-92

10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) > 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)
Marketing Start Date2017-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3481-92 [00781348192]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-30

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/10mL

OpenFDA Data

SPL SET ID:50605463-2dc2-4b27-bc51-4d87bb9a8539
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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