Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Mas Management Group, Inc.
Mas Management Group, Inc.
079363782
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tramadol Hydrochloride
Product Details
NDC Product Code
69677-316Application Number
NDA022370Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 10, 2017TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TramadolActive
Code: 9N7R477WCKClass: ACTIBQuantity: 150 mg in 1 1
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BIClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50MClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT