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Durela Prescribing Information

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

Medically reviewed by Drugs.com. Last updated on Dec 21, 2022.

Durela 100 mg

Durela 100 mg_30 caps

Durela 200 mg

Durela 200 mg_Bottle of 30 caps

Durela 300 mg

Durela 300 mg_capsules

DURELA
tramadol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-239
Route of AdministrationORALDEA ScheduleCIV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeG252;100
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-239-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/31/2011
DURELA
tramadol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-242
Route of AdministrationORALDEA ScheduleCIV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize23mm
FlavorImprint CodeG254;300
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-242-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/31/2011
DURELA
tramadol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-241
Route of AdministrationORALDEA ScheduleCIV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeG253;200
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-241-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/31/2011
Labeler - Galephar Pharmaceutical Research Inc. (003551624)
Registrant - Galephar Pharmaceutical Research Inc. (003551624)
Establishment
NameAddressID/FEIBusiness Operations
Galephar Pharmaceutical Research Inc003551624analysis(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
NameAddressID/FEIBusiness Operations
Galephar Pharmaceutical Research Inc.968996160analysis(66277-239, 66277-241, 66277-242)

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