Methylphenidate Hydrochloride (Page 10 of 10)

Package/Label Display Panel – Blister – 54 mg

54 mg Methylphenidate Hydrochloride Extended-Release Tablet Blister
(click image for full-size original)

Methylphenidate Hydrochloride
Extended-Release Tablet, USP   54 mg   CII

METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-532(NDC:31722-952)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 18 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE ACETATE
HYPROMELLOSE, UNSPECIFIED
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERRIC OXIDE YELLOW
FD&C RED NO. 40
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POLYSORBATE 80
BUTYLATED HYDROXYTOLUENE
Product Characteristics
Color yellow (light yellow to yellow) Score no score
Shape ROUND (cylindrical) Size 12mm
Flavor Imprint Code 212
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-532-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-532-11)
1 NDC:60687-532-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-532-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211009 06/25/2020 02/29/2024
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-543(NDC:31722-953)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 27 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CELLULOSE ACETATE
HYPROMELLOSE, UNSPECIFIED
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERRIC OXIDE YELLOW
FD&C RED NO. 40
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color pink (light pink to pink) Score no score
Shape ROUND (cylindrical) Size 12mm
Flavor Imprint Code 213
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-543-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-543-11)
1 NDC:60687-543-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-543-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211009 06/25/2020 04/30/2024
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-554(NDC:31722-954)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 36 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CELLULOSE ACETATE
HYPROMELLOSE, UNSPECIFIED
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERRIC OXIDE YELLOW
FD&C RED NO. 40
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
Product Characteristics
Color white (White to off white) Score no score
Shape ROUND (cylindrical) Size 15mm
Flavor Imprint Code 214
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-554-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-554-11)
1 NDC:60687-554-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-554-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211009 06/25/2020 04/30/2024
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-565(NDC:31722-955)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 54 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CELLULOSE ACETATE
HYPROMELLOSE, UNSPECIFIED
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERRIC OXIDE YELLOW
FD&C RED NO. 40
TITANIUM DIOXIDE
FERRIC OXIDE RED
TALC
FERROSOFERRIC OXIDE
Product Characteristics
Color brown (light to dark brown) Score no score
Shape ROUND (cylindrical) Size 15mm
Flavor Imprint Code 215
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-565-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-565-11)
1 NDC:60687-565-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-565-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211009 06/25/2020 03/31/2024
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-532), repack (60687-543), repack (60687-554), repack (60687-565)

Revised: 01/2023 American Health Packaging

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