Dexmethylphenidate Hydrochloride (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 2.5 mg:

NDC 10702- 0106 -01

Dexmethylphenidate Hydrochloride Tablets CII

2.5 mg

Pharmacist: Dispense with accompanying Medication Guide to each patient.

100 Tablets Rx Only

KVK TECH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 5 mg:

NDC 10702- 0107 -01

Dexmethylphenidate Hydrochloride Tablets CII

5 mg

Pharmacist: Dispense with accompanying Medication Guide to each patient.

100 Tablets Rx Only

KVK TECH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 10 mg:

NDC 10702- 0108 -01

Dexmethylphenidate Hydrochloride Tablets CII

10 mg

Pharmacist: Dispense with accompanying Medication Guide to each patient.

100 Tablets Rx Only

KVK TECH

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-106 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE FD&C BLUE NO. 1

Product Characteristics Color blue Score no score Shape ROUND Size 7mm Flavor Imprint Code A;1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10702-106-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206931 12/04/2015

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-107 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE D&C YELLOW NO. 10

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A;2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10702-107-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206931 12/04/2015

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-108 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE

Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code A;3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10702-108-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206931 12/04/2015

Labeler — KVK-TECH, INC (173360061)

Registrant — Abhai, Inc. (964490432)

Establishment
Name	Address	ID/FEI	Operations
KVK-TECH, INC		173360061	manufacture (10702-106), manufacture (10702-107), manufacture (10702-108)

Revised: 12/2022 KVK-TECH, INC