Methylphenidate Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label-5 mg

NDC 10702- 0100 -01

Methylphenidate Hydrochloride Tablets, USP

5 mg CII

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- 0101 -01

Methylphenidate Hydrochloride Tablets, USP

10 mg CII

Pharmacist: Dispense with accompanying Medication Guide to each patient.

100 Tablets Rx Only

KVK-TECH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label-20 mg

NDC 10702- 0102 -01

Methylphenidate Hydrochloride Tablets, USP

20 mg CII

Pharmacist: Dispense with accompanying Medication Guide to each patient.

100 Tablets Rx Only

KVK-TECH

METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-100 Route of Administration ORAL DEA Schedule CII

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

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE STARCH, CORN TALC D&C YELLOW NO. 10 MAGNESIUM STEARATE

Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code K;100 Contains

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

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206932 05/11/2017

METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-101 Route of Administration ORAL DEA Schedule CII

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

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE STARCH, CORN TALC D&C YELLOW NO. 10 MAGNESIUM STEARATE FD&C BLUE NO. 1

Product Characteristics Color green (Pale Green) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code K;101 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10702-101-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206932 05/11/2017

METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-102 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 20 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE STARCH, CORN TALC D&C YELLOW NO. 10 MAGNESIUM STEARATE

Product Characteristics Color yellow (light yellow) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code K;102 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10702-102-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206932 05/11/2017

Labeler — KVK-TECH, INC. (173360061)

Registrant — Abhai, Inc. (964490432)

Establishment
Name	Address	ID/FEI	Operations
KVK-TECH, INC.		173360061	manufacture (10702-100), manufacture (10702-101), manufacture (10702-102)

Revised: 01/2022 KVK-TECH, INC.