NDC Code 70771-1341-5 - Metoprolol Succinate

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METOPROLOL SUCCINATE(UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)	METOPROLOL	25 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1338-1	100 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
2	NDC:70771-1338-5	500 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
3	NDC:70771-1338-0	1000 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METOPROLOL SUCCINATE(UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)	METOPROLOL	50 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1339-1	100 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
2	NDC:70771-1339-5	500 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
3	NDC:70771-1339-0	1000 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METOPROLOL SUCCINATE(UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)	METOPROLOL	100 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1340-1	100 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
2	NDC:70771-1340-5	500 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
3	NDC:70771-1340-0	1000 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METOPROLOL SUCCINATE(UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)	METOPROLOL	200 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1341-1	100 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
2	NDC:70771-1341-5	500 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018
3	NDC:70771-1341-0	1000 in 1 BOTTLE Type 0: Not a Combination Product	06/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

NDC 70771-1339-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 50 mg

Rx only

100 Tablets

NDC 70771-1340-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 100 mg

Rx only

100 Tablets

NDC 70771-1341-1 in bottles of 100 Tablets

Metoprolol Succinate Extended-release Tablets USP, 200 mg

Rx only

100 Tablets

NDC 70771-1341-5
API & Excipient Details

Metoprolol Succinate marketed by Zydus Lifesciences Limited under NDC Code 70771-1341-5

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

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 70771-1341-5 API & Excipient Details

Metoprolol Succinate marketed by Zydus Lifesciences Limited under NDC Code 70771-1341-5

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, 70771-1341-0Packager : Zydus Lifesciences Limited

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 70771-1341-5
API & Excipient Details

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