NDC Code(s) : 55700-976-90
Packager : Quality Care Products, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metoprolol SuccinateMetoprolol Succinate ER Tablets TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:55700-976(NDC:67877-590)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
WATER(UNII: 059QF0KO0R)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (off white) Score 2 pieces
Shape OVAL Size 12 mm
Flavor Imprint Code A;3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-976-9090 in 1 BOTTLE Type 0: Not a Combination Product19/07/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211143 07/19/2022

LABELER - Quality Care Products, LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Quality Care Products, LLC 831276758 repack(55700-976)

PRINCIPAL DISPLAY PANEL

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