Metoprolol Tartrate (Page 5 of 5)

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Aurobindo Pharma USA, Inc. as follows:
(25 mg / 100 UD) NDC 62584-265-01 packaged from NDC 65862-062
(50 mg / 100 UD) NDC 62584-266-01 packaged from NDC 65862-063
(100 mg / 100 UD) NDC 62584-267-01 packaged from NDC 65862-064

Distributed by:
American Health Packaging Columbus, OH 43217

8026501/0722

Package/Label Display Panel – Carton – 25 mg

25mg Metoprolol Tartrate Tablets Carton
(click image for full-size original)

NDC 62584- 265 -01

Metoprolol Tartrate
Tablets, USP

25 mg

100 Tablets (10 x 10)               Rx Only

Each Film-Coated Tablet Contains:
Metoprolol tartrate, USP. …………………………………………………. 25 mg

Usual Dosage: See full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from light and moisture.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 65862-062, Aurobindo Pharma USA, Inc.

Distributed by: American Health Packaging, Columbus, Ohio 43217

026501 0026501/0923

Package/Label Display Panel – Blister – 25 mg

25mg Metoprolol Tartrate Tablets Blister
(click image for full-size original)

Metoprolol Tartrate Tablet, USP

25 mg

Package/Label Display Panel – Carton – 50 mg

50 mg Metoprolol Tartrate Tablets Carton
(click image for full-size original)

NDC 62584- 266 -01

Metoprolol Tartrate
Tablets, USP

50 mg

100 Tablets (10 x 10)               Rx Only

Each Film-Coated Tablet Contains:
Metoprolol Tartrate, USP…………………………………………….50 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from light and moisture.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTON: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65862-063, Aurobindo Pharma USA, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

026601 0026601/1122

Package/Label Display Panel – Blister – 50 mg

50 mg Metoprolol Tartrate Tablet Blister
(click image for full-size original)

Metoprolol
Tartrate Tablet, USP

50 mg

Package/Label Display Panel – Carton – 100 mg

100 mg Metoprolol Tartrate Tablets Carton
(click image for full-size original)

NDC 62584- 267 -01

Metoprolol Tartrate
Tablets, USP

100 mg

100 Tablets (10 x 10)               Rx Only

Each Film-Coated Tablet Contains:
Metoprolol tartrate, USP……………………………….100 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].
Protect from light and moisture.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTON: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 65862-064, Aurobindo Pharma USA, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

026701 0026701/0918OS

Package/Label Display Panel – Blister – 100 mg

100mg Metoprolol Tartrate Tablets Blister
(click image for full-size original)

Metoprolol Tartrate Tablet, USP

100 mg

METOPROLOL TARTRATE metoprolol tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62584-266(NDC:65862-063)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C RED NO. 30
Product Characteristics
Color pink Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code C;74
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62584-266-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (62584-266-11)
1 NDC:62584-266-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (62584-266-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077739 06/22/2010
METOPROLOL TARTRATE metoprolol tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62584-265(NDC:65862-062)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code C;73
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62584-265-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (62584-265-11)
1 NDC:62584-265-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (62584-265-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077739 06/09/2010
METOPROLOL TARTRATE metoprolol tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62584-267(NDC:65862-064)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FD&C BLUE NO. 2
Product Characteristics
Color blue (Light Blue) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code C;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62584-267-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (62584-267-11)
1 NDC:62584-267-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (62584-267-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077739 07/26/2010
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (62584-265), repack (62584-266), repack (62584-267)

Revised: 03/2024 American Health Packaging

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.