NDC Code(s) : 43598-438-01, 43598-439-01, 43598-440-01, 43598-441-01
Packager : Dr.Reddys Laboratories Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate HydrochlorideMethylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-438
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride(UNII: 4B3SC438HI)
(Methylphenidate - UNII:207ZZ9QZ49) 		Methylphenidate Hydrochloride18 mg
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Cellulose Acetate(UNII: 3J2P07GVB6)
Fd&C Blue No. 1(UNII: H3R47K3TBD)
Fd&C Blue No. 2(UNII: L06K8R7DQK)
Fd&C Red No. 40(UNII: WZB9127XOA)
Ferrosoferric Oxide(UNII: XM0M87F357)
Hypromellose 2910 (3 Mpa.S)(UNII: 0VUT3PMY82)
Hypromellose 2910 (6 Mpa.S)(UNII: 0WZ8WG20P6)
Phosphoric Acid(UNII: E4GA8884NN)
Poloxamer 188(UNII: LQA7B6G8JG)
Polyethylene Glycol, Unspecified(UNII: 3WJQ0SDW1A)
Polyethylene Glycol 7000000(UNII: G3MS6M810Y)
Polyethylene Glycol 2000000(UNII: 5K3991GVWI)
Polysorbate 80(UNII: 6OZP39ZG8H)
Povidone K30(UNII: U725QWY32X)
Propylene Glycol(UNII: 6DC9Q167V3)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Sodium Chloride(UNII: 451W47IQ8X)
Stearic Acid(UNII: 4ELV7Z65AP)
Succinic Acid(UNII: AB6MNQ6J6L)
Titanium Dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color PURPLE Score no score
Shape CAPSULE Size 12 mm
Flavor Imprint Code RDY18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-438-01100 in 1 BOTTLE Type 0: Not a Combination Product20/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213473 08/20/2020
Methylphenidate HydrochlorideMethylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-439
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride(UNII: 4B3SC438HI)
(Methylphenidate - UNII:207ZZ9QZ49) 		Methylphenidate Hydrochloride27 mg
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Cellulose Acetate(UNII: 3J2P07GVB6)
D&C Red No. 27(UNII: 2LRS185U6K)
Fd&C Blue No. 1(UNII: H3R47K3TBD)
Fd&C Blue No. 2(UNII: L06K8R7DQK)
Fd&C Red No. 40(UNII: WZB9127XOA)
Ferrosoferric Oxide(UNII: XM0M87F357)
Hypromellose 2910 (3 Mpa.S)(UNII: 0VUT3PMY82)
Hypromellose 2910 (6 Mpa.S)(UNII: 0WZ8WG20P6)
Phosphoric Acid(UNII: E4GA8884NN)
Poloxamer 188(UNII: LQA7B6G8JG)
Polyethylene Glycol, Unspecified(UNII: 3WJQ0SDW1A)
Polyethylene Glycol 7000000(UNII: G3MS6M810Y)
Polyethylene Glycol 2000000(UNII: 5K3991GVWI)
Polysorbate 80(UNII: 6OZP39ZG8H)
Povidone K30(UNII: U725QWY32X)
Propylene Glycol(UNII: 6DC9Q167V3)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Sodium Chloride(UNII: 451W47IQ8X)
Stearic Acid(UNII: 4ELV7Z65AP)
Succinic Acid(UNII: AB6MNQ6J6L)
Titanium Dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 12 mm
Flavor Imprint Code RDY27
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-439-01100 in 1 BOTTLE Type 0: Not a Combination Product20/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213473 08/20/2020
Methylphenidate HydrochlorideMethylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-440
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride(UNII: 4B3SC438HI)
(Methylphenidate - UNII:207ZZ9QZ49) 		Methylphenidate Hydrochloride36 mg
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Cellulose Acetate(UNII: 3J2P07GVB6)
Fd&C Blue No. 1(UNII: H3R47K3TBD)
Fd&C Red No. 40(UNII: WZB9127XOA)
Fd&C Yellow No. 6(UNII: H77VEI93A8)
Ferrosoferric Oxide(UNII: XM0M87F357)
Hypromellose 2910 (3 Mpa.S)(UNII: 0VUT3PMY82)
Hypromellose 2910 (6 Mpa.S)(UNII: 0WZ8WG20P6)
Phosphoric Acid(UNII: E4GA8884NN)
Poloxamer 188(UNII: LQA7B6G8JG)
Polyethylene Glycol, Unspecified(UNII: 3WJQ0SDW1A)
Polyethylene Glycol 7000000(UNII: G3MS6M810Y)
Polyethylene Glycol 2000000(UNII: 5K3991GVWI)
Polysorbate 80(UNII: 6OZP39ZG8H)
Povidone K30(UNII: U725QWY32X)
Propylene Glycol(UNII: 6DC9Q167V3)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Sodium Chloride(UNII: 451W47IQ8X)
Stearic Acid(UNII: 4ELV7Z65AP)
Succinic Acid(UNII: AB6MNQ6J6L)
Titanium Dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code RDY36
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-440-01100 in 1 BOTTLE Type 0: Not a Combination Product20/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213473 08/20/2020
Methylphenidate HydrochlorideMethylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-441
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylphenidate Hydrochloride(UNII: 4B3SC438HI)
(Methylphenidate - UNII:207ZZ9QZ49) 		Methylphenidate Hydrochloride54 mg
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Cellulose Acetate(UNII: 3J2P07GVB6)
Fd&C Blue No. 1(UNII: H3R47K3TBD)
Fd&C Blue No. 2(UNII: L06K8R7DQK)
Fd&C Red No. 40(UNII: WZB9127XOA)
Ferrosoferric Oxide(UNII: XM0M87F357)
Hypromellose 2910 (3 Mpa.S)(UNII: 0VUT3PMY82)
Hypromellose 2910 (6 Mpa.S)(UNII: 0WZ8WG20P6)
Phosphoric Acid(UNII: E4GA8884NN)
Poloxamer 188(UNII: LQA7B6G8JG)
Polyethylene Glycol, Unspecified(UNII: 3WJQ0SDW1A)
Polyethylene Glycol 7000000(UNII: G3MS6M810Y)
Polyethylene Glycol 2000000(UNII: 5K3991GVWI)
Polysorbate 80(UNII: 6OZP39ZG8H)
Povidone K30(UNII: U725QWY32X)
Propylene Glycol(UNII: 6DC9Q167V3)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Sodium Chloride(UNII: 451W47IQ8X)
Stearic Acid(UNII: 4ELV7Z65AP)
Succinic Acid(UNII: AB6MNQ6J6L)
Titanium Dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code RDY54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-441-01100 in 1 BOTTLE Type 0: Not a Combination Product20/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213473 08/20/2020

LABELER - Dr.Reddys Laboratories Inc(802315887)

Establishment
Name Address ID/FEI Business Operations
Dr. Reddy's Laboratories LLC. 830397282 analysis(43598-438, 43598-439, 43598-440, 43598-441), manufacture(43598-438, 43598-439, 43598-440, 43598-441)

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg - 100's Count

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Tablets USP, 27 mg - 100's Count

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Tablets USP, 36 mg - 100's Count

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Tablets USP, 54 mg - 100's Count