NDC Code(s) : 70771-1338-1, 70771-1338-5, 70771-1338-0, 70771-1339-1, 70771-1339-5, 70771-1339-0, 70771-1340-1, 70771-1340-5, 70771-1340-0, 70771-1341-1, 70771-1341-5, 70771-1341-0
Packager : Zydus Lifesciences Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

metoprolol succinate metoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1338
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
GLYCERIN(UNII: PDC6A3C0OX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (15 CPS)(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:70771-1338-1100 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
2NDC:70771-1338-5500 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
3NDC:70771-1338-01000 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203894 06/07/2018
metoprolol succinate metoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1339
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
GLYCERIN(UNII: PDC6A3C0OX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (15 CPS)(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 ROUND Size 10 mm
Flavor Imprint Code 565
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70771-1339-1100 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
2NDC:70771-1339-5500 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
3NDC:70771-1339-01000 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203894 06/07/2018
metoprolol succinate metoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1340
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE(UNII: TH25PD4CCB)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
GLYCERIN(UNII: PDC6A3C0OX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (15 CPS)(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 ROUND Size 12 mm
Flavor Imprint Code 566
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70771-1340-1100 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
2NDC:70771-1340-5500 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
3NDC:70771-1340-01000 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203894 06/07/2018
metoprolol succinate metoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1341
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE(UNII: TH25PD4CCB)
(METOPROLOL - UNII:GEB06NHM23) 		METOPROLOL200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
GLYCERIN(UNII: PDC6A3C0OX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (15 CPS)(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 20 mm
Flavor Imprint Code 5;67
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70771-1341-1100 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
2NDC:70771-1341-5500 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
3NDC:70771-1341-01000 in 1 BOTTLE Type 0: Not a Combination Product06/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203894 06/07/2018

LABELER - Zydus Lifesciences Limited(918596198)

REGISTRANT - Zydus Lifesciences Limited(863362789)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1338, 70771-1339, 70771-1340, 70771-1341), MANUFACTURE(70771-1338, 70771-1339, 70771-1340, 70771-1341)

PRINCIPAL DISPLAY PANEL

NDC 70771-1338-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 25 mg

Rx only

100 Tablets

figure

NDC 70771-1339-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 50 mg

Rx only

100 Tablets

figure

NDC 70771-1340-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 100 mg

Rx only

100 Tablets

figure

NDC 70771-1341-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 200 mg

Rx only

100 Tablets

figure