NDC Code(s) : 68788-8448-3, 68788-8448-6, 68788-8448-9, 68788-8448-1
Packager : Preferred Pharmaceuticals Inc

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:68788-8448(NDC:72516-032)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE(UNII: W5S57Y3A5L)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL TARTRATE100 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code e701
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-8448-330 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
2NDC:68788-8448-660 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
3NDC:68788-8448-990 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
4NDC:68788-8448-1100 in 1 BOTTLE Type 0: Not a Combination Product15/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207206 05/15/2023

LABELER - Preferred Pharmaceuticals Inc(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc 791119022 REPACK(68788-8448)

PRINCIPAL DISPLAY PANEL

NDC 68788-8448

Metoprolol Succinate Extended-Release Tablets

100 mg*

Rx only

Metoprolol Succinate Extended-Release Tab USP 100mg