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Durela

Package insert / prescribing information
Generic name: tramadol hydrochloride
Dosage form: capsule, extended release
Drug class: Opioids (narcotic analgesics)

Medically reviewed by Drugs.com. Last updated on Dec 1, 2022.

Durela 100 mg

Durela 200 mg

Durela 300 mg

Durela
tramadol hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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 (TRAMADOL) TRAMADOL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYPROMELLOSE 2910 (6 MPA.S)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
SUCROSE STEARATE
MAGNESIUM STEARATE
TALC
STARCH, CORN
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G252;100
Contains
Packaging
# Item Code Package Description
1 NDC:66277-239-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
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 LABEL 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 (TRAMADOL) TRAMADOL HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
SUCROSE STEARATE
MAGNESIUM STEARATE
TALC
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code G254;300
Contains
Packaging
# Item Code Package Description
1 NDC:66277-242-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
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 LABEL 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 (TRAMADOL) TRAMADOL HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
SUCROSE STEARATE
MAGNESIUM STEARATE
TALC
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code G253;200
Contains
Packaging
# Item Code Package Description
1 NDC:66277-241-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
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 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 Operations
Galephar Pharmaceutical Research Inc. 968996160 analysis(66277-239, 66277-241, 66277-242)
Galephar Pharmaceutical Research Inc.

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