NDC Code(s) : 72888-080-01, 72888-080-05, 72888-080-00, 72888-008-01, 72888-008-05, 72888-008-00
Packager : Advagen Pharma Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tramadol HydrochlorideTramadol Hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-080
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 HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape CAPSULE Size 13 mm
Flavor Imprint Code 018
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-080-01100 in 1 BOTTLE Type 0: Not a Combination Product24/07/2023
2NDC:72888-080-05500 in 1 BOTTLE Type 0: Not a Combination Product24/07/2023
3NDC:72888-080-001000 in 1 BOTTLE Type 0: Not a Combination Product24/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208708 07/24/2023
Tramadol HydrochlorideTramadol Hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-008
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape CAPSULE Size 15 mm
Flavor Imprint Code 019
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-008-01100 in 1 BOTTLE Type 0: Not a Combination Product24/02/2020
2NDC:72888-008-05500 in 1 BOTTLE Type 0: Not a Combination Product24/02/2020
3NDC:72888-008-001000 in 1 BOTTLE Type 0: Not a Combination Product24/02/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208708 02/24/2020

LABELER - Advagen Pharma Limited(051627256)

REGISTRANT - Rubicon Research Private Limited(918629544)

Establishment
Name Address ID/FEI Business Operations
Rubicon Research Private Limited 677604197 analysis(72888-080, 72888-008), manufacture(72888-080, 72888-008)

PRINCIPAL DISPLAY PANEL

NDC 72888-080-01

100 Tablets

Tramadol Hydrochloride Tablets, USP

50 mg

Rx only

Rubicon Research Private Limited

tramadol-hcl-tabs-usp-50-mg-100s

NDC 72888-080-05

500 Tablets

Tramadol Hydrochloride Tablets, USP

50 mg

Rx only

Rubicon Research Private Limited

tramadol-hcl-tabs-usp-50-mg-100s

NDC 72888-080-00

1,000 Tablets

Tramadol Hydrochloride Tablets, USP

50 mg

Rx only

Rubicon Research Private Limited

tramadol-hcl-tabs-usp-50-mg-100s

PRINCIPAL DISPLAY PANEL

NDC 72888-008-01

100 Tablets

Tramadol Hydrochloride Tablets, USP

100 mg

Rx only

Rubicon Research Private Limited

tramadol-hcl-tabs-usp-100-mg-100s

NDC 72888-008-05

500 Tablets

Tramadol Hydrochloride Tablets, USP

100 mg

Rx only

Rubicon Research Private Limited

tramadol-hcl-tabs-usp-100-mg-100s

NDC 72888-008-00

1,000 Tablets

Tramadol Hydrochloride Tablets, USP

100 mg

Rx only

Rubicon Research Private Limited

tramadol-hcl-tabs-usp-100-mg-100s