Tygacil
These highlights do not include all the information needed to use TYGACIL safely and effectively. See full prescribing information for TYGACIL. TYGACIL (tigecycline) for injection, for intravenous useInitial U.S. Approval: 2005
Approved
Approval ID
fd826e47-1b77-4ffd-bb22-fda3379903b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2022
Manufacturers
FDA
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
DUNS: 113008515
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TIGECYCLINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-4994
Application NumberNDA021821
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIGECYCLINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2021
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TIGECYCLINEActive
Quantity: 50 mg in 5 mL
Code: 70JE2N95KR
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTOSE MONOHYDRATEInactive
Quantity: 100 mg in 5 mL
Code: EWQ57Q8I5X
Classification: IACT