NDC Code(s) : 10702-183-50, 10702-171-03
Packager : KVK-Tech, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxycodone HydrochlorideOxycodone Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-183
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 in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROCHLORIC ACID(UNII: QTT17582CB)
MALTITOL(UNII: D65DG142WK)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCRALOSE(UNII: 96K6UQ3ZD4)
WATER(UNII: 059QF0KO0R)
BERRY(UNII: FV3431923Z)
SORBITOL(UNII: 506T60A25R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color red Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-183-501 in 1 CARTON 21/07/2017
1500 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208593 07/21/2017
OXYCODONE HYDROCHLORIDEoxycodone hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-171
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 HYDROCHLORIDE100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROCHLORIC ACID(UNII: QTT17582CB)
MALTITOL(UNII: D65DG142WK)
BERRY(UNII: FV3431923Z)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SORBITOL(UNII: 506T60A25R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color yellow Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-171-031 in 1 CARTON 21/07/2017
130 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208593 07/21/2017

LABELER - KVK-Tech, Inc.(173360061)

REGISTRANT - ABHAI, LLC.(079385868)

Establishment
Name Address ID/FEI Business Operations
KVK-Tech, Inc. 173360061 manufacture(10702-183, 10702-171)

PRINCIPAL DISPLAY PANEL

NDC 10702- 183-50

Oxycodone  Hydrochloride  Oral Solution, USP  CII

5 mg per 5 mL

(1 mg per 1 mL)

Pharmacist: Dispense  the accompnying  Medication Guide  to each patient

SUGAR FREE .  ALCOHOL FREE

R X Only     500 mL

KVK-TECH, INC.

5 mg container label

PRINCIPAL DISPLAY PANEL

NDC 10702- 171-03

Oxycodone  Hydrochloride  Oral Solution, USP  CII

100 mg per 5 mL

(20 mg per 1 mL)

Pharmacist: Dispense the  accompnying  Medication  Guide to each patients.

ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT

SUGAR FREE . ALCOHOL FREE

R X Only     30 mL

KVK-TECH, INC.

100 mg container label

PRINCIPAL DISPLAY PANEL

NDC 10702- 171-03

Oxycodone Hydrochloride Oral Solution, USP CII

100 mg per 5 mL

(20 mg per 1 mL)

CAUTION! HIGHLY CONCENTRATED SOLUTION!

VERIFY DOSAGE AND MEASURE CAREFULLY!

Pharmacist: Dispense the enclosed Medication Guide to each patients.

ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT

SUGAR FREE . ALCOHOL FREE

Each 5 mL of Oxycodone Hydrochloride Oral Solution contains 100 mg Oxycodone Hydrochloride. (Each 1 mL of Oxycodone Hydrochloride Oral Solution contains 20 mg Oxycodone Hydrochloride).

R X only Containes: 1 X 30 mL bottle

KVK-TECH, INC.

100mg/5mL Carton

PRINCIPAL DISPLAY PANEL

NDC 10702- 183-50

Oxycodone Hydrochloride Oral Solution, USP CII

5 mg per 5 mL

(1 mg per 1 mL)

Pharmacist: Dispense the enclosed Medication Guide to each patient.

SUGAR FREE . ALCOHOL FREE

R X only

Contains: 1 X 500 mL bottle

KVK-TECH, INC.

5mg/5mL Carton