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

2.5 mg container label
(click image for full-size original)

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

5 mg container label
(click image for full-size original)

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

10 mg container label
(click image for full-size original)
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: 01/2022 KVK-TECH, INC

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