NDC Code(s) : 50090-5419-0
Packager : A-S Medication Solutions

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:50090-5419(NDC:68382-564)
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
GLYCERIN(UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (15 MPA.S)(UNII: NPU9M2E6L8)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE K30(UNII: U725QWY32X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code 564
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-5419-090 in 1 BOTTLE Type 0: Not a Combination Product28/12/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203894 06/07/2018

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-5419), REPACK(50090-5419)

PRINCIPAL DISPLAY PANEL

Label Image