Dexmethylphenidate Hydrochloride (Page 8 of 8)

Package/Label Display Panel

NDC 0093-5550-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

5 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5551-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

10 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5552-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

15 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5553-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

20 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5045-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

25 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5554-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

30 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5046-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

35 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

Package/Label Display Panel

NDC 0093-5562-01

Dexmethylphenidate Hydrochloride Extended-Release Capsules CII

40 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Capsules

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5550 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C BLUE NO. 1

Product Characteristics Color blue (aqua-blue) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code TEVA;5550 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5550-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078908 11/10/2014

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5551 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10

Product Characteristics Color white (ivory) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code TEVA;5551 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5551-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078908 02/02/2015

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5552 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C GREEN NO. 3

Product Characteristics Color blue (blue-green) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code TEVA;5552 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5552-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078908 05/21/2014

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5553 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color white Score no score Shape CAPSULE Size 19mm Flavor Imprint Code TEVA;5553 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5553-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078908 06/22/2015

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5045 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C BLUE NO. 1

Product Characteristics Color blue (aqua-blue) , white Score no score Shape CAPSULE Size 22mm Flavor Imprint Code TEVA;5045 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5045-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202731 07/05/2017

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5554 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10

Product Characteristics Color white (ivory) , white Score no score Shape CAPSULE Size 23mm Flavor Imprint Code TEVA;5554 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5554-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202731 05/22/2014

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5046 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10 FD&C BLUE NO. 1

Product Characteristics Color blue (aqua-blue) , white (ivory) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code TEVA;5046 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5046-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202731 07/05/2017

DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5562 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE B D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN, UNSPECIFIED HYPROMELLOSE 2208 (3 MPA.S) FERROSOFERRIC OXIDE METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SUCROSE POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C BLUE NO. 1 FD&C GREEN NO. 3

Product Characteristics Color blue (blue-green) , white Score no score Shape CAPSULE Size 23mm Flavor Imprint Code TEVA;5562 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5562-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202731 11/21/2013

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 01/2022 Teva Pharmaceuticals USA, Inc.