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
R_x only

Once Daily 90 Capsules

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
R_x only

Once Daily 90 Capsules

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
R_x only

Once Daily 90 Capsules

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
R_x only

Once Daily 90 Capsules

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
R_x only

Once Daily 90 Capsules

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
R_x only

Once Daily 90 Capsules

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
R_x only

Once Daily 90 Capsules

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