Prescription Drug Information: Methylphenidate Hydrochloride (Page 8 of 8)

Package/Label Display Panel – Carton – 18 mg

18 mg Methylphenidate Hydrochloride Extended-Release Tablets Carton
(click image for full-size original)

NDC 60687- 532 -21

Methylphenidate
Hydrochloride     CII
Extended-Release Tablets, USP

18 mg

30 Tablets (3 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains 18 mg methylphenidate hydrochloride in a
controlled-release formulation.

Usual Dosage: Once daily. See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from humidity.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

DEA Order Form Required.

The drug product contained in this package is from
NDC # 31722-952, Camber Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

753221 0453221/1019

Package/Label Display Panel – Blister – 18 mg

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

Methylphenidate Hydrochloride
Extended-Release Tablet, USP   18 mg   CII

Package/Label Display Panel – Carton – 27 mg

27 mg Methylphenidate Hydrochloride Extended-Release Tablets Carton
(click image for full-size original)

NDC 60687- 543 -21

Methylphenidate
Hydrochloride      CII
Extended-Release Tablets, USP

27 mg

30 Tablets (3 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains 27 mg methylphenidate hydrochloride in a
controlled-release formulation.

Usual Dosage: Once daily. See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from humidity.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

DEA Order Form Required.

The drug product contained in this package is from
NDC # 31722-953, Camber Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

754321 0454321/1019

Package/Label Display Panel – Blister – 27 mg

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

Methylphenidate Hydrochloride
Extended-Release Tablet, USP   27 mg   CII

Package/Label Display Panel – Carton – 36 mg

36 mg Methylphenidate Hydrochloride Extended-Release Tablets Carton
(click image for full-size original)

NDC 60687- 554 -21

Methylphenidate
Hydrochloride      CII
Extended-Release Tablets, USP

36 mg

30 Tablets (3 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains 36 mg methylphenidate hydrochloride in a
controlled-release formulation.

Usual Dosage: Once daily. See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from humidity.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

DEA Order Form Required.

The drug product contained in this package is from
NDC # 31722-954, Camber Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

755422 0455421/1019

Package/Label Display Panel – Blister – 36 mg

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

Methylphenidate Hydrochloride
Extended-Release Tablet, USP   36 mg   CII

Package/Label Display Panel – Carton – 54 mg

54 mg Methylphenidate Hydrochloride Extended-Release Tablets Carton
(click image for full-size original)

NDC 60687- 565 -21

Methylphenidate
Hydrochloride      CII
Extended-Release Tablets, USP

54 mg

30 Tablets (3 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains 54 mg methylphenidate hydrochloride in a
controlled-release formulation.

Usual Dosage: Once daily. See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from humidity.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

DEA Order Form Required.

The drug product contained in this package is from
NDC # 31722-955, Camber Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

756521 0456521/1019

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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