Northwind Pharmaceuticals LLC

FDA Drug Class II Ongoing

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-3

August 20, 2025 Northwind Pharmaceuticals LLC a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles units

FDA Drug Class II Ongoing

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52

March 16, 2023 Northwind Pharmaceuticals LLC 6 bottles units

FDA Drug Class II Ongoing

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

March 16, 2023 Northwind Pharmaceuticals LLC a) 230 bottles; b) 22 bottles units

FDA Drug Class II Ongoing

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52

March 16, 2023 Northwind Pharmaceuticals LLC 99 bottles units

FDA Drug Class II Ongoing

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52

March 16, 2023 Northwind Pharmaceuticals LLC 33 bottles units

FDA Drug Class II Ongoing

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52

March 16, 2023 Northwind Pharmaceuticals LLC 23 bottles units

FDA Drug Class II Ongoing

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

March 16, 2023 Northwind Pharmaceuticals LLC a) 198 bottles; b) 22 bottles units

FDA Drug Class II Ongoing

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

March 16, 2023 Northwind Pharmaceuticals LLC a)164 bottles; b) 198 bottles units

FDA Drug Class II Terminated

Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52

July 18, 2018 Northwind Pharmaceuticals LLC 14 bottles units

FDA Drug Class II Terminated

Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52

July 18, 2018 Northwind Pharmaceuticals LLC 2 bottles units

FDA Drug Class II Terminated

Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52

July 18, 2018 Northwind Pharmaceuticals LLC 68 bottles units

FDA Drug Class II Terminated

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

July 18, 2018 Northwind Pharmaceuticals LLC 43 bottles units

FDA Drug Class III Terminated

Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: No

November 10, 2015 Northwind Pharmaceuticals LLC 40 Bottles units