NDC Code(s) : 68025-053-05, 68025-053-30, 68025-055-30, 68025-056-30
Packager : Vertical Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ConZiptramadol hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-053
Route of Administration ORAL DEA Schedule
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
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SUCROSE STEARATE(UNII: 274KW0O50M)
POVIDONE K29/32(UNII: 390RMW2PEQ)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TALC(UNII: 7SEV7J4R1U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 19 mm
Flavor Imprint Code G;252;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68025-053-055 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
2NDC:68025-053-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022370 08/31/2011 02/28/2017
ConZiptramadol hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-055
Route of Administration ORAL DEA Schedule
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
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
D&C RED NO. 7(UNII: ECW0LZ41X8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SUCROSE STEARATE(UNII: 274KW0O50M)
POVIDONE K29/32(UNII: 390RMW2PEQ)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TALC(UNII: 7SEV7J4R1U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 22 mm
Flavor Imprint Code G;253;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68025-055-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022370 08/31/2011 03/31/2017
ConZiptramadol hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-056
Route of Administration ORAL DEA Schedule
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
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
D&C RED NO. 7(UNII: ECW0LZ41X8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SUCROSE STEARATE(UNII: 274KW0O50M)
POVIDONE K29/32(UNII: 390RMW2PEQ)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TALC(UNII: 7SEV7J4R1U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 23 mm
Flavor Imprint Code G;254;300
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68025-056-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022370 08/31/2011 04/30/2016

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 100 mg Bottle Label

NDC 68025-053-05

Conzip™

(tramadol hydrochloride)

extended-release capsules

100 mg per capsule

Professional Sample - Not for Sale

Once daily

Rx only

5 Capsules

Principal Display Panel – 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 100 mg Bottle Label

NDC 68025-053-30

Conzip™

(tramadol hydrochloride)

extended-release capsules

100 mg per capsule

Once daily

Rx only

30 Capsules

Principal Display Panel – 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 200 mg Bottle Label

NDC 68025-055-30

Conzip™

(tramadol hydrochloride)

extended-release capsules

200 mg per capsule

Once daily

Rx only

30 Capsules

Principal Display Panel – 200 mg Bottle Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 300 mg Bottle Label

NDC 68025-056-30

Conzip™

(tramadol hydrochloride)

extended-release capsules

300 mg per capsule

Once daily

Rx only

30 Capsules

Principal Display Panel – 300 mg Bottle Label