Metoprolol Succinate ER (Page 5 of 5)

References

1. Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008; 371:1839-47.

Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

How Supplied

Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10×10).

Bottles of 30 NDC 55111-468-30

Bottles of 60 NDC 55111-468-60

Bottles of 100 NDC 55111-468-01

Bottles of 500 NDC 55111-468-05

Unit dose packages of 100 (10×10) NDC 55111-468-78

Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10×10).

Bottles of 30 NDC 55111-469-30

Bottles of 60 NDC 55111-469-60

Bottles of 100 NDC 55111-469-01

Bottles of 500 NDC 55111-469-05

Unit dose packages of 100 (10×10) NDC 55111-469-78

Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]


Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

Patient Counseling Information

Advise patients to take metoprolol succinate extended-release tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue metoprolol succinate extended-release tablets without consulting the physician.

Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with metoprolol succinate extended-release tablets has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking metoprolol succinate extended-release tablets.

Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.

PLENDIL is a trademark of the AstraZeneca group of companies.

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally — 500 090 INDIA

Revised: 1212

Repackaged By:

Northwind Pharmaceuticals, LLC

Indianapolis, IN 46256


Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

Package Label.Principal Display Panel

NDC: 51655-573-52

MFG: 55111-468-05

Metoprolol Succinate ER 100 mg

30 Tablets

Rx Only

Lot#:

Exp.Date:

Each film-coated tablet contains 95 mg metoprolol succinate equivalent to 100mg metoprolol tartrate, USP.

Dosage: See prescriber’s instructions.

Store at 68 to 77 degrees F.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg. by: Dr. Reddy’s Laboratories Limited Bachupally — 500 090 India Lot#

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-573-52
(click image for full-size original)
METOPROLOL SUCCINATE ER metoprolol succinate er tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-573(NDC:55111-468)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
POLYETHYLENE GLYCOL 6000
SODIUM STEARYL FUMARATE
TALC
ACETYLTRIBUTYL CITRATE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYDROGENATED COTTONSEED OIL
METHYLENE CHLORIDE
ETHYLCELLULOSE (10 MPA.S)
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code M;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-573-52 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078889 04/07/2016
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-573)

Revised: 04/2016 Northwind Pharmaceuticals

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