NDC Code(s) : 50458-657-30, 50458-655-30, 50458-653-30
Packager : Janssen Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ultram ERTramadol Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-657
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
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 9 mm
Flavor Imprint Code 300;ER
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50458-657-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021692 10/01/2005
Ultram ERTramadol Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-655
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 HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient Name Strength
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 8 mm
Flavor Imprint Code 200;ER
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50458-655-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021692 10/01/2005
Ultram ERTramadol Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-653
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 HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 6 mm
Flavor Imprint Code 100;ER
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50458-653-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021692 10/01/2005

PRINCIPAL DISPLAY PANEL

NDC 50458-657-30

CIV

ONCE DAILY

ULTRAM® ER

(tramadol HCl) Extended-Release Tablets

300 mg

30 tablets

Rx only

janssen

ultram-er-06.jpg

PRINCIPAL DISPLAY PANEL

NDC 50458-655-30

CIV

ONCE DAILY

ULTRAM® ER

(tramadol HCl) Extended-Release Tablets

200 mg

30 tablets

Rx only

janssen

ultram-er-07.jpg

PRINCIPAL DISPLAY PANEL

NDC 50458-653-30

CIV

ONCE DAILY

ULTRAM® ER

(tramadol HCl) Extended-Release Tablets

100 mg

30 tablets

Rx only

Janssen

ultram-er-08.jpg