DURELA- tramadol hydrochloride capsule, extended release

Durela by

Drug Labeling and Warnings

Durela by is a Prescription medication manufactured, distributed, or labeled by Galephar Pharmaceutical Research Inc., Galephar Pharmaceutical Research Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Durela 100 mg

Durela 200 mg

Durela 300 mg

INGREDIENTS AND APPEARANCE

DURELA 
tramadol hydrochloride capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-239
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 HYDROCHLORIDE	100 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)
SUCROSE STEARATE (UNII: 274KW0O50M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	G252;100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-239-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

DURELA 
tramadol hydrochloride capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-242
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 HYDROCHLORIDE	300 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)
SUCROSE STEARATE (UNII: 274KW0O50M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	23mm
Flavor		Imprint Code	G254;300
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-242-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

DURELA 
tramadol hydrochloride capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-241
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 HYDROCHLORIDE	200 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)
SUCROSE STEARATE (UNII: 274KW0O50M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	G253;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-241-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

Labeler - Galephar Pharmaceutical Research Inc. (003551624)

Registrant - Galephar Pharmaceutical Research Inc. (003551624)

Establishment
Name	Address	ID/FEI	Business Operations
Galephar Pharmaceutical Research Inc		003551624	analysis(66277-239, 66277-241, 66277-242) , label(66277-239, 66277-241, 66277-242) , manufacture(66277-239, 66277-241, 66277-242) , pack(66277-239, 66277-241, 66277-242)

Establishment
Name	Address	ID/FEI	Business Operations
Galephar Pharmaceutical Research Inc.		968996160	analysis(66277-239, 66277-241, 66277-242)