Methylphenidate Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label

NDC 42858-075-45
CII

Methylphenidate
HCl Extended-Release
Capsules

10 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 10 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mg Capsule Bottle Label

NDC 42858-076-45
CII

Methylphenidate
HCl Extended-Release
Capsules

15 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 15 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Bottle Label

NDC 42858-077-45
CII

Methylphenidate
HCl Extended-Release
Capsules

20 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 20 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg Capsule Bottle Label

NDC 42858-078-45
CII

Methylphenidate
HCl Extended-Release
Capsules

30 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 30 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Capsule Bottle Label

NDC 42858-079-45
CII

Methylphenidate
HCl Extended-Release
Capsules

40 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 40 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Capsule Bottle Label

NDC 42858-080-45
CII

Methylphenidate
HCl Extended-Release
Capsules

50 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 50 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg Capsule Bottle Label

NDC 42858-081-45
CII

Methylphenidate
HCl Extended-Release
Capsules

60 mg

Dispense the accompanying
Medication Guide to each patient.

Rhodes
Rx only

Once Daily 90 Capsules

PRINCIPAL DISPLAY PANEL -- 60 mg Capsule Bottle Label
(click image for full-size original)
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-075
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
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
FD&C Blue No. 1
Propylene Glycol
Ferrosoferric oxide
Potassium hydroxide
Product Characteristics
Color TURQUOISE (light turquoise blue opaque) , WHITE (opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RP;910
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-075-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-076
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride (Methylphenidate) Methylphenidate Hydrochloride 15 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
D&C Red No. 28
D&C Yellow No. 10
FD&C Red No. 40
Propylene Glycol
Ferrosoferric oxide
Potassium hydroxide
Product Characteristics
Color ORANGE, WHITE (opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RP;915
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-076-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-077
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
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
D&C RED NO. 33
D&C Yellow No. 10
Propylene Glycol
Ferrosoferric oxide
Potassium hydroxide
Product Characteristics
Color YELLOW (opaque) , WHITE (opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code RP;920
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-077-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-078
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride (Methylphenidate) Methylphenidate Hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
FD&C Blue No. 1
FD&C Red No. 3
Propylene Glycol
Ferrosoferric oxide
Potassium hydroxide
Product Characteristics
Color BLUE (blue violet) , WHITE (opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code RP;930
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-078-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-079
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride (Methylphenidate) Methylphenidate Hydrochloride 40 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
D&C Red No. 28
FD&C Blue No. 1
FD&C Red No. 40
Propylene Glycol
Ferrosoferric oxide
Potassium hydroxide
Product Characteristics
Color PINK (opaque) , WHITE (opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RP;940
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-079-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-080
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride (Methylphenidate) Methylphenidate Hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
D&C Yellow No. 10
FD&C Green No. 3
Propylene Glycol
Ferrosoferric oxide
Potassium hydroxide
Product Characteristics
Color GREEN (opaque) , WHITE (opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code RP;950
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-080-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-081
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride (Methylphenidate) Methylphenidate Hydrochloride 60 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Starch, corn
Hypromellose, unspecified
Polyethylene glycol, unspecified
AMMONIO METHACRYLATE COPOLYMER TYPE B
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Triethyl citrate
Talc
Water
Silicon dioxide
Titanium dioxide
Gelatin, unspecified
Ferrosoferric Oxide
Propylene Glycol
Potassium hydroxide
Product Characteristics
Color GRAY (opaque) , WHITE (opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code RP;960
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-081-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA205831 04/01/2020
Labeler — Rhodes Pharmaceuticals (831928986)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 MANUFACTURE (42858-075), MANUFACTURE (42858-076), MANUFACTURE (42858-077), MANUFACTURE (42858-078), MANUFACTURE (42858-079), MANUFACTURE (42858-080), MANUFACTURE (42858-081)

Revised: 06/2021 Rhodes Pharmaceuticals

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