Digoxin tablet

Ingredients and appearance - Product information

Digoxin tablet- Digoxin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55289-002
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Digoxin ( UNII: 73K4184T59)( Digoxin - UNII: 73K4184T59 ) 125 ugin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Aluminum oxide ( UNII: LMI26O6933)
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color yellow Imprint Code JSP;544
Score 2 Shape ROUND
Size 6 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 55289-002-30 30 in 1 BOTTLE, PLASTIC 2012/02/15
2 NDC: 55289-002-01 100 in 1 BOTTLE, PLASTIC 2012/02/15

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076268 USA 2012/02/15

Labeler - PD-Rx Pharmaceuticals, Inc.( 156893695)

Establishment

Name ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack( 55289-002)
For example, 125 mcg Digoxin Tablets equivalent to 125 mcg Digoxin Elixir Pediatric equivalent to 100 mcg Digoxin Solution in Capsules equivalent to 100 mcg Digoxin Injection/IV.
Documented for ventricular response rate in atrial fibrillation, inotropic effects and electrocardiographic changes.
Depending upon rate of infusion.
Number of patients with an event during the first 2 years per 1000 randomized patients.
Relative risk (95% confidence interval).
DIG Ancillary Study.
Ccr is creatinine clearance, corrected to 70 kg body weight or 1.73 m 2 body surface area. For adults, if only serum creatinine concentrations (Scr) are available, a Ccr (corrected to 70 kg body weight) may be estimated in men as (140 - Age)/Scr. For women, this result should be multiplied by 0.85. Note: This equation cannot be used for estimating creatinine clearance in infants or children.
If no loading dose administered.
62.5 mcg = 0.0625 mg