NDC Code(s) : 72603-142-01, 72603-142-02, 72603-142-03, 72603-143-01, 72603-143-02, 72603-143-03
Packager : Northstar Rx LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metoprolol succinateMetoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72603-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE(UNII: TH25PD4CCB)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL25 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Hydroxypropyl Cellulose, Unspecified(UNII: 9XZ8H6N6OH)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
Product Characteristics
Color WHITE Score 2
Shape OVAL Size 10 mm
Flavor Imprint Code M;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72603-142-01100 in 1 BOTTLE Type 0: Not a Combination Product04/10/2023
2NDC:72603-142-02500 in 1 BOTTLE Type 0: Not a Combination Product04/10/2023
3NDC:72603-142-031000 in 1 BOTTLE Type 0: Not a Combination Product09/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090617 04/10/2023
Metoprolol succinateMetoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72603-143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE(UNII: TH25PD4CCB)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL50 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Hydroxypropyl Cellulose, Unspecified(UNII: 9XZ8H6N6OH)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
Product Characteristics
Color WHITE Score 2
Shape ROUND Size 9 mm
Flavor Imprint Code M;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72603-143-01100 in 1 BOTTLE Type 0: Not a Combination Product04/10/2023
2NDC:72603-143-02500 in 1 BOTTLE Type 0: Not a Combination Product04/10/2023
3NDC:72603-143-031000 in 1 BOTTLE Type 0: Not a Combination Product09/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090617 04/10/2023

LABELER - Northstar Rx LLC(830546433)

Establishment
Name Address ID/FEI Business Operations
Dr. Reddy's Laboratories Limited-FTO 3 918608162 analysis(72603-142, 72603-143), manufacture(72603-142, 72603-143)

PRINCIPAL DISPLAY PANEL

25 mg Container label - 100's Count

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

PRINCIPAL DISPLAY PANEL

50 mg Container label: - 100's Count

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number