NDC Code(s) : 35356-898-30, 35356-898-60, 35356-898-90, 35356-888-30, 35356-888-60, 35356-888-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METOPROLOL SUCCINATEMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-898(NDC:64679-735)
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
TALC(UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (Circular, beveled edge) Size 11 mm
Flavor Imprint Code W;735
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-898-3030 in 1 BOTTLE
2NDC:35356-898-6060 in 1 BOTTLE
3NDC:35356-898-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090615 07/22/2010
METOPROLOL SUCCINATEMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-888(NDC:64679-736)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE(UNII: TH25PD4CCB)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
TALC(UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (Circular, beveled edge) Size 12 mm
Flavor Imprint Code W;736
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-888-3030 in 1 BOTTLE
2NDC:35356-888-6060 in 1 BOTTLE
3NDC:35356-888-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090615 07/22/2010

PRINCIPAL DISPLAY PANEL

Image of 50mg Label

PRINCIPAL DISPLAY PANEL

Image of 100mg Label