NDC Code(s) : 72516-030-01, 72516-030-50, 72516-030-10, 72516-031-01, 72516-031-50, 72516-031-10, 72516-032-01, 72516-032-50, 72516-032-10, 72516-033-01
Packager : Oryza 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:72516-030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE(UNII: W5S57Y3A5L)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL TARTRATE25 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)
CELLULOSE, MICROCRYSTALLINE(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 OVAL Size 7 mm
Flavor Imprint Code e7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72516-030-01100 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
2NDC:72516-030-50500 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
3NDC:72516-030-101000 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207206 04/27/2022
Metoprolol SuccinateMetoprolol Succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72516-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE(UNII: W5S57Y3A5L)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL TARTRATE50 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)
CELLULOSE, MICROCRYSTALLINE(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 8 mm
Flavor Imprint Code e71
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72516-031-01100 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
2NDC:72516-031-50500 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
3NDC:72516-031-101000 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207206 04/27/2022
Metoprolol SuccinateMetoprolol Succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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)
CELLULOSE, MICROCRYSTALLINE(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:72516-032-01100 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
2NDC:72516-032-50500 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
3NDC:72516-032-101000 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207206 04/27/2022
Metoprolol SuccinateMetoprolol Succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72516-033
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE(UNII: W5S57Y3A5L)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL TARTRATE200 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)
CELLULOSE, MICROCRYSTALLINE(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 OVAL Size 18 mm
Flavor Imprint Code e702
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72516-033-01100 in 1 BOTTLE Type 0: Not a Combination Product27/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207206 04/27/2022

LABELER - Oryza Pharmaceuticals, Inc(080337493)

REGISTRANT - Visum Pharmaceutical Co., Ltd.(421344638)

Establishment
Name Address ID/FEI Business Operations
Visum Pharmaceutical Co., Ltd. 421344638 MANUFACTURE(72516-030), manufacture(72516-031, 72516-032, 72516-033), analysis(72516-030, 72516-031, 72516-032, 72516-033), pack(72516-030, 72516-031, 72516-032, 72516-033)

PRINCIPAL DISPLAY PANEL

NDC 72516-030-01

Metoprolol Succinate Extended-Release Tablets

25 mg*

Rx only

100 Tablets

Label

NDC 72516-031-01

Metoprolol Succinate Extended-Release Tablets

50 mg*

Rx only

100 Tablets

Label

NDC 72516-032-01

Metoprolol Succinate Extended-Release Tablets

100 mg*

Rx only

100 Tablets

Label

NDC 72516-033-01

Metoprolol Succinate Extended-Release Tablets

200 mg*

Rx only

100 Tablets

Label