ASPRUZYO SPRINKLE (Page 6 of 6)

Package/Label Display Panel

NDC 47335-624-30

ASPRUZYO Sprinkle™ (ranolazine) extended-release granules

500 mg per sachet

Rx only SUN PHARMA

Contains 30 sachets

Package/Label Display Panel

NDC 47335-624-60

ASPRUZYO Sprinkle™ (ranolazine) extended-release granules

500 mg per sachet

Rx only SUN PHARMA

Contains 60 sachets

Package/Label Display Panel

NDC 47335-624-11

ASPRUZYO Sprinkle™ (ranolazine) extended-release granules

500 mg per sachet

Each sachet contains 500 mg ranolazine

Recommended Dosage: See prescribing information.

Rx only SUN PHARMA

This package is child-resistant.

Keep out of reach of children.

ASPRUZYO SPRINKLE ranolazine granule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-624 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANOLAZINE (RANOLAZINE) RANOLAZINE 500 mg

Inactive Ingredients Ingredient Name Strength DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE TALC MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Product Characteristics Color WHITE (white to off-white) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47335-624-30 30 GRANULE in 1 CARTON None 2 NDC:47335-624-60 60 GRANULE in 1 CARTON None 3 NDC:47335-624-11 1 GRANULE in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA216018 02/28/2022

ASPRUZYO SPRINKLE ranolazine granule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-625 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANOLAZINE (RANOLAZINE) RANOLAZINE 1000 mg

Inactive Ingredients Ingredient Name Strength DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER DIBUTYL SEBACATE ETHYLCELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE TALC MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Product Characteristics Color WHITE (white to off-white) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47335-625-30 30 GRANULE in 1 CARTON None 2 NDC:47335-625-60 60 GRANULE in 1 CARTON None 3 NDC:47335-625-11 1 GRANULE in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA216018 02/28/2022

Labeler — SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)

Registrant — SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)

Establishment
Name	Address	ID/FEI	Operations
Sun Pharmaceutical Industries Limited		650456002	MANUFACTURE (47335-624), MANUFACTURE (47335-625)

Revised: 03/2022 SUN PHARMACEUTICAL INDUSTRIES, INC.