tramadol hydrochloride
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IVInitial U.S. Approval: 1995
Approved
Approval ID
f3c7d874-8f9e-4687-9dac-2356ecfa86f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
ACI Healthcare USA, Inc.
DUNS: 080430318
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 Code71093-119
Application NumberANDA202075
Product Classification
M
Marketing Category
C73584
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2022
FDA Product Classification
INGREDIENTS (10)
TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT