NDC Code(s) : 68001-469-00, 68001-469-08, 68001-470-00, 68001-470-08, 68001-471-00
Packager : BluePoint Laboratories

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:68001-469
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code C;L;407
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-469-00100 in 1 BOTTLE Type 0: Not a Combination Product08/04/2023
2NDC:68001-469-081000 in 1 BOTTLE Type 0: Not a Combination Product08/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207465 08/04/2023
METOPROLOL SUCCINATEmetoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-470
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
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code C;L;408
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-470-00100 in 1 BOTTLE Type 0: Not a Combination Product08/04/2023
2NDC:68001-470-081000 in 1 BOTTLE Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207465 08/04/2023
METOPROLOL SUCCINATEmetoprolol succinate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-471
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
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 19 mm
Flavor Imprint Code C;L;409
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-471-00100 in 1 BOTTLE Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207465 08/04/2023

LABELER - BluePoint Laboratories(985523874)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Limited- Indore 918596409 manufacture(68001-469, 68001-470, 68001-471), analysis(68001-469, 68001-470, 68001-471)

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 68001-469-00

Metoprolol Succinate

Extended-Release

Tablets, USP

50mg*

CAUTION

Verify Product Dispensed

100 Tablets

Bluepoint Laboratories

Label: Metoprolol Succinate ER tablets USP 50 mg

Rx Only

NDC 68001-470-00

Metoprolol Succinate Extended-Release Tablets, USP

100mg*

Caution

Verify Product Dispensed

100 Tablets

Bluepoint Laboratories

Label: Metoprolol Succinate ER tablets USP 50 mg

Rx Only

NDC 68001-471-00

Metoprolol Succinate Extended-Release Tablets, USP

200mg*

Caution

Verify Product Dispensed

100 Tablets

Bluepoint Laboratories

Label: Metoprolol Succinate ER tablets USP 50 mg