NDC Code(s) : 0904-6322-61, 0904-6322-06, 0904-6323-61
Packager : Major Pharmaceuticals

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:0904-6322(NDC:55111-466)
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
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code M;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6322-61100 in 1 CARTON 09/10/2012
11 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0904-6322-0650 in 1 CARTON 09/10/2012
21 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090617 09/10/2012
Metoprolol succinateMetoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6323(NDC:55111-467)
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
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code M;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6323-61100 in 1 CARTON 09/10/2012
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090617 09/10/2012

LABELER - Major Pharmaceuticals(191427277)

PRINCIPAL DISPLAY PANEL

Metoprolol Succinate Extended-Release Tablets USP

25 mg*

100 Tablets

Carton label

PRINCIPAL DISPLAY PANEL

Metoprolol Succinate Extended-Release Tablets USP

50 mg*

100 Tablets

Carton Label