NDC Code(s) : 72319-021-02, 72319-022-02
Packager : i3 Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RANOLAZINERANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72319-021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANOLAZINE(UNII: A6IEZ5M406)
(RANOLAZINE - UNII:A6IEZ5M406) 		RANOLAZINE500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
Product Characteristics
Color orange Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code I3;21
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72319-021-0260 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213517 06/15/2022
RANOLAZINERANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72319-022
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANOLAZINE(UNII: A6IEZ5M406)
(RANOLAZINE - UNII:A6IEZ5M406) 		RANOLAZINE1000 mg
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYDEXTROSE(UNII: VH2XOU12IE)
TALC(UNII: 7SEV7J4R1U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 21 mm
Flavor Imprint Code I3;22
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72319-022-0260 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213517 06/15/2022

LABELER - i3 Pharmaceuticals, LLC(080127275)

REGISTRANT - i3 Pharmaceuticals, LLC(080127275)

Establishment
Name Address ID/FEI Business Operations
i3 Pharmaceuticals, LLC 080127275 manufacture(72319-021, 72319-022), pack(72319-021, 72319-022)

PRINCIPAL DISPLAY PANEL

NDC 72319-021-02

60 Tablets

Ranolazine Extended-Release Tablets

500 mg

Each film-coated, extended-release tablet contains 500 mg of ranolazine.

Dispense with Patient Information in package insert.

i3 Pharmaceuticals, LLC

Rx Only

container-500mg-60tablets

NDC 72319-022-02

60 Tablets

Ranolazine Extended-Release Tablets

1,000 mg

Each film-coated, extended-release tablet contains 1,000 mg of ranolazine.

Dispense with Patient Information in package insert.

i3 Pharmaceuticals, LLC

Rx Only

container-500mg-60tablets