Tigecycline
These highlights do not include all the information needed to use TIGECYCLINE FOR INJECTION safely and effectively. See full prescribing information for TIGECYCLINE FOR INJECTION. TIGECYCLINE for injection, for intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
230484a8-408c-dcc1-d0c4-d9dd9a46831b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 13, 2023
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
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 Code60505-6098
Application NumberANDA204439
Product Classification
M
Marketing Category
C73584
G
Generic Name
TIGECYCLINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 13, 2023
FDA Product Classification
INGREDIENTS (4)
TIGECYCLINEActive
Quantity: 50 mg in 5 mL
Code: 70JE2N95KR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Quantity: 100 mg in 5 mL
Code: EWQ57Q8I5X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT