NDC Code(s) : 49884-823-11, 49884-822-11, 49884-821-11
Packager : Par Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TRAMADOL HYDROCHLORIDEtramadol hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-823
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 (100000 MW)(UNII: 949E52Z6MY)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 8 mm
Flavor Imprint Code Par823
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-823-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078783 06/28/2012 02/28/2019
TRAMADOL HYDROCHLORIDEtramadol hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-822
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 (100000 MW)(UNII: 949E52Z6MY)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 8 mm
Flavor Imprint Code Par822
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-822-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078783 06/28/2012 03/31/2019
TRAMADOL HYDROCHLORIDEtramadol hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-821
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 (100000 MW)(UNII: 949E52Z6MY)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 6 mm
Flavor Imprint Code Par821
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-821-1130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078783 06/28/2012 10/31/2018

PRINCIPAL DISPLAY PANEL

Tramadol HCl ER Tablets, 300 mg label

PRINCIPAL DISPLAY PANEL

Tramadol HCl ER Tablets, 200 mg label

PRINCIPAL DISPLAY PANEL

Tramadol HCl ER Tablets, 100 mg label