NDC 60505-6098

Tigecycline

Tigecycline

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

Product ID60505-6098_4aa44f74-7798-5f52-1910-bf10c1e53604
NDC60505-6098
Product TypeHuman Prescription Drug
Proprietary NameTigecycline
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-04-09
Marketing CategoryANDA / ANDA
Application NumberANDA204439
Labeler NameApotex Corp
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/5mL
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60505-6098-1

10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2019-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-6098-1 [60505609801]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-09

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/5mL

OpenFDA Data

SPL SET ID:230484a8-408c-dcc1-d0c4-d9dd9a46831b
Manufacturer
UNII

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.