Isosorbide dinitrate how supplied storage and handling: Difference between revisions

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==Supply Storage and Handling==
==Supply==
Isordil<sup>®</sup> (isosorbide dinitrate) Oral Titradose™ Tablets are available as follows:


Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;
* 5 mg, round, pink tablets imprinted "BPI 152" on one side and deeply scored on reverse side:
NDC 64455-152-01, bottles of 100.


Debossed “WW 773” on Scored side.
* 40 mg, round, light green tablets imprinted "BPI 192" on one side and deeply scored on reverse side:
NDC 64455-192-01, bottles of 100.


Bottles of 30 tablets.
==Storage and Handling==


Bottles of 100 tablets.


Bottles of 500 tablets.
* Store at controlled room temperature, 25°C (77°F); excursions permitted to 15 -30° (59-86°F)


Bottles of 1000 tablets.
* Protect from light.


Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
* Keep bottles tightly closed.


Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:
* Dispense in a light-resistant, tight container.
 
2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.
 
5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.
 
Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:
 
5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.
 
10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.
 
20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.
 
Manufactured by:
 
West-ward Pharmaceutical Corp.
 
Eatontown, NJ 07724
 
Revised December 2010<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ISORDIL (ISOSORBIDE DINITRATE) TABLET [BTA PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abb3ad49-73a8-49c5-adc5-164d052971d7 | publisher =  | date =  | accessdate = 30 January 2014 }}</ref>


Isordil<sup>®</sup> is a registered trade mark of Biovail Laboratories International SRL.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ISORDIL (ISOSORBIDE DINITRATE) TABLET [BTA PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abb3ad49-73a8-49c5-adc5-164d052971d7 | publisher =  | date =  | accessdate = 30 January 2014 }}</ref>
==References==
==References==



Revision as of 15:14, 31 January 2014

Isosorbide dinitrate
ISORDIL® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Description
Clinical Pharmacology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

Supply

Isordil® (isosorbide dinitrate) Oral Titradose™ Tablets are available as follows:

  • 5 mg, round, pink tablets imprinted "BPI 152" on one side and deeply scored on reverse side:

NDC 64455-152-01, bottles of 100.

  • 40 mg, round, light green tablets imprinted "BPI 192" on one side and deeply scored on reverse side:

NDC 64455-192-01, bottles of 100.

Storage and Handling

  • Store at controlled room temperature, 25°C (77°F); excursions permitted to 15 -30° (59-86°F)
  • Protect from light.
  • Keep bottles tightly closed.
  • Dispense in a light-resistant, tight container.

Isordil® is a registered trade mark of Biovail Laboratories International SRL.[1]

References

  1. "ISORDIL (ISOSORBIDE DINITRATE) TABLET [BTA PHARMACEUTICALS, INC.]". Retrieved 30 January 2014.