tramadol hydrochloride
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE ORAL SOLUTION. TRAMADOL HYDROCHLORIDE oral solution C-IV Initial U.S. Approval: 1995
Approved
Approval ID
2804c640-9d47-4b40-b58b-da321b79cf39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Palmetto Pharmaceuticals, Inc.
DUNS: 963291864
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 Code68134-402
Application NumberNDA214044
Product Classification
M
Marketing Category
C73605
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (8)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 9N7R477WCK
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT