Amlodipine Besylate (Page 3 of 3)

Nonclinical toxicology

3.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5 mg, 1.25 mg, or 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. 3 For the rat, the highest dose was, on a mg/m2 basis, about twice the maximum recommended human dose. *

Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level.

There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose3 of 10 mg/day on a mg/m2 basis).

*Based on patient weight of 50 kg

Principal display panel

NDC:51655-054-52

MFG: 31722-238-10

Amlodipine Besylate 5 MG

30 Tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains amlodipine besylate, USP equivalent to 5 mg amlodipine.

Dosage: See prescribing information

Store at 68-77 degrees F.

Protect from light and moisture.

Store in a tight, light-resistant container.

Keep out of the reach of children.

Mfg. by Invagen Pharmaceuticals, Hauppage, NY 11788

Mfg for Camber Pharmaceuticals, Piscataway, NJ 08854 Lot #

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-054-52
(click image for full-size original)
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-054(NDC:31722-238)
Route of Administration Oral DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 238;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-054-52 30 TABLET in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 09/23/2014
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-054)

Revised: 09/2014 Northwind Pharmaceuticals, LLC

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