NDC Code(s) : 72189-521-30
Packager : Direct_Rx

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tramadol HCL ERTramadol HCL ER TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72189-521(NDC:68180-699)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE(UNII: 9N7R477WCK)
(TRAMADOL - UNII:39J1LGJ30J) 		TRAMADOL HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POVIDONE(UNII: FZ989GH94E)
SHELLAC(UNII: 46N107B71O)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white ((white to off-white)) Score no score
Shape ROUND ((biconvex)) Size 10 mm
Flavor Imprint Code L012
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72189-521-3030 in 1 BOTTLE Type 0: Not a Combination Product11/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200503 11/08/2023

LABELER - Direct_Rx(079254320)

REGISTRANT - Direct_Rx(079254320)

Establishment
Name Address ID/FEI Business Operations
Direct_Rx 079254320 repack(72189-521)

PRINCIPAL DISPLAY PANEL

72189-521-30