Methylphenidate Hydrochloride (Page 4 of 4)

2.5 mg
(click image for full-size original)

5 mg
(click image for full-size original)
10 mg
(click image for full-size original)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-125
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
GUAR GUM
STARCH, PREGELATINIZED CORN
STEARIC ACID
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor grape Imprint Code 260;AT
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-125-01 100 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210354 02/17/2020
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-126
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
ASPARTAME
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
GUAR GUM
STARCH, PREGELATINIZED CORN
STEARIC ACID
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor grape Imprint Code 261;AT
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-126-01 100 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210354 02/17/2020
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-127
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
ASPARTAME
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
GUAR GUM
STARCH, PREGELATINIZED CORN
STEARIC ACID
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 13mm
Flavor grape Imprint Code AT;262
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-127-01 100 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210354 02/17/2020
Labeler — XLCare Pharmaceuticals, Inc (080991142)
Registrant — Ascent Pharmaceuticals, Inc (080938961)
Establishment
Name Address ID/FEI Operations
Ascent Pharmaceuticals, Inc 080938961 manufacture (72865-125), manufacture (72865-126), manufacture (72865-127), analysis (72865-125), analysis (72865-126), analysis (72865-127), pack (72865-125), pack (72865-126), pack (72865-127)

Revised: 08/2021 XLCare Pharmaceuticals, Inc

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