Ultram ER (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

NDC 50458-655-30

ONCE DAILY
ULTRAM® ER

(tramadol HCl) Extended-Release Tablets

200 mg

30 tablets

Rx only

PriCara ®
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL -- 200 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 50458-653-30

ONCE DAILY
ULTRAM® ER

(tramadol HCl) Extended-Release Tablets

100 mg

30 tablets

Rx only

PriCara ®
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)
ULTRAM ER tramadol hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-657
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tramadol Hydrochloride (Tramadol) Tramadol Hydrochloride 300 mg
Inactive Ingredients
Ingredient Name Strength
dibutyl sebacate
ethylcellulose (100 MPA.S)
sodium stearyl fumarate
silicon dioxide
polyvinyl alcohol
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 9mm
Flavor Imprint Code 300;ER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-657-30 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021692 10/01/2005
ULTRAM ER tramadol hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-655
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tramadol Hydrochloride (Tramadol) Tramadol Hydrochloride 200 mg
Inactive Ingredients
Ingredient Name Strength
dibutyl sebacate
ethylcellulose (100 MPA.S)
sodium stearyl fumarate
silicon dioxide
polyvinyl alcohol
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 8mm
Flavor Imprint Code 200;ER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-655-30 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021692 10/01/2005
ULTRAM ER tramadol hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-653
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tramadol Hydrochloride (Tramadol) Tramadol Hydrochloride 100 mg
Inactive Ingredients
Ingredient Name Strength
dibutyl sebacate
ethylcellulose (100 MPA.S)
sodium stearyl fumarate
silicon dioxide
polyvinyl alcohol
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 6mm
Flavor Imprint Code 100;ER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-653-30 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021692 10/01/2005
Labeler — Ortho-McNeil-Janssen Pharmaceuticals, Inc. (063137772)
Registrant — Valeant Pharmaceuticals International, Inc. (245141858)
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc. 253292734 MANUFACTURE

Revised: 02/2011 Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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