NDC Code(s) : 63629-9170-1
Packager : Bryant Ranch Prepack

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 Item Code (Source) NDC:63629-9170(NDC:67877-591)
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
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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(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 ROUND Size 11 mm
Flavor Imprint Code A50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-9170-1500 in 1 BOTTLE Type 0: Not a Combination Product27/11/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211143 11/27/2020

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-9170), RELABEL(63629-9170)

PRINCIPAL DISPLAY PANEL

Metoprolol Succinate ER 50 mg tab#500

Label