Label: DIGOXIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-001-52 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0527-1324
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 16, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-001-52
MFG: 0527-1324-10
Digoxin 0.125 MG
30 Tablets
Rx Only
Lot# NW41850001
EXP Date: 12/2015
Each tablet contains Digoxin, USP...0.125mg
Dosage: See package insert
Store at 59 to 77 degrees F in a dry place and protect from light.
Store in a tight, light resistant container (See USP). Keep out of the reach of children.
Mfg by: Jerome Stevens Pharmaceuticals, Inc Bohemia, NY 11716
Mfg for: Lannett Co. Inc, Philadelphia, PA 19136 Lot # 038813
Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
DIGOXIN
digoxin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-001(NDC:0527-1324) Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59) DIGOXIN 0.125 mg in 30 Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code JSP544 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-001-52 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076268 05/16/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-001)