NDC Code(s) : 10702-018-01, 10702-018-50, 10702-056-01, 10702-056-50, 10702-008-01, 10702-008-50, 10702-057-01, 10702-057-50, 10702-009-01, 10702-009-50
Packager : KVK-TECH,INC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-018
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code K;18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-018-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:10702-018-50500 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091393 10/18/2013
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-056
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color pink Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code K;56
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-056-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:10702-056-50500 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091393 10/18/2013
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-008
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code K;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-008-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:10702-008-50500 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091393 10/18/2013
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-057
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color gray Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code K;57
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-057-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:10702-057-50500 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091393 10/18/2013
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-009
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code K;9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-009-01100 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:10702-009-50500 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091393 10/18/2013

LABELER - KVK-TECH,INC(173360061)

REGISTRANT - KVK-TECH, INC(173360061)

Establishment
Name Address ID/FEI Business Operations
KVK-TECH, INC 173360061 manufacture(10702-018, 10702-056, 10702-008, 10702-057, 10702-009)

PRINCIPAL DISPLAY PANEL

Pack Size: 100 Tablets:

NDC 10702- 018-01

Oxycodone Hydrochloride Tablets, USP CII

5 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 TABLETS

KVK-Tech, Inc.

5 mg-100s

Pack Size: 500 Tablets:

NDC 10702- 018-50

Oxycodone Hydrochloride Tablets, USP CII

5 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

500 TABLETS

KVK-Tech, Inc.

5 mg-100s

PRINCIPAL DISPLAY PANEL

Pack Size: 100 Tablets:

NDC 10702- 056-01

Oxycodone Hydrochloride Tablets, USP CII

10 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 TABLETS

KVK-Tech, Inc.

10 mg-100s

Pack Size: 500 Tablets:

NDC 10702- 056-50

Oxycodone Hydrochloride Tablets, USP CII

10 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

500 TABLETS

KVK-Tech, Inc.

10 mg-100s

PRINCIPAL DISPLAY PANEL

Pack Size: 100 Tablets:

NDC 10702- 008-01

Oxycodone Hydrochloride Tablets, USP CII

15 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 TABLETS

KVK-Tech, Inc.

15 mg-100s

Pack Size: 500 Tablets:

NDC 10702- 008-50

Oxycodone Hydrochloride Tablets, USP CII

15 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

500 TABLETS

KVK-Tech, Inc.

15 mg-100s

PRINCIPAL DISPLAY PANEL

Pack Size: 100 Tablets:

NDC 10702- 057-01

Oxycodone Hydrochloride Tablets, USP CII

20 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 TABLETS

KVK-Tech, Inc.

20 mg-100s

Pack Size: 500 Tablets:

NDC 10702- 057-50

Oxycodone Hydrochloride Tablets, USP CII

20 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

500 TABLETS

KVK-Tech, Inc.

20 mg-100s

PRINCIPAL DISPLAY PANEL

Pack Size: 100 Tablets:

NDC 10702- 009-01

Oxycodone Hydrochloride Tablets, USP CII

30 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 TABLETS

KVK-Tech, Inc.

30 mg-100s

Pack Size: 500 Tablets:

NDC 10702- 009-50

Oxycodone Hydrochloride Tablets, USP CII

30 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

500 TABLETS

KVK-Tech, Inc.

30 mg-100s