QDOLO
These highlights do not include all the information needed to use QDOLO safely and effectively. See full prescribing information for QDOLO. QDOLO (tramadol hydrochloride) oral solution C-IV Initial U.S. Approval: 1995
Approved
Approval ID
949661c5-2b98-46f9-a002-7e73f1e00952
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Athena Bioscience, LLC
DUNS: 080710928
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71511-301
Application NumberNDA214044
Product Classification
M
Marketing Category
C73594
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (8)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 9N7R477WCK
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT