NDC 61919-040
Losartan Potassium And Hydrochlorothiazide 50 mg / 12.5 mg tablet
On the label: Direct Rx. It's repackaged from NDC 13668-116, made by Torrent Pharmaceuticals Limited (Losartan Potassium and Hydrochlorothiazide). That product's FDA listing has since ended, so its label and factories are no longer published.
Where the pills inside were made
This label doesn't name the factory that makes the drug (it lists 1 site that repackages it and relabels it). Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Direct Rx names for other drugs.
Recalls
- Mar 12, 2019 · Class II · Direct Rx
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Lots: Lot: 12DE1806 Exp. 01/31/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydrochlorothiazide and Losartan: every company that makes it
- Form
- tablet
- Strength
- 50 mg / 12.5 mg
- Approval
- ANDA ANDA090528
- On the market since
- Jan 1, 2015
- Package NDCs
61919-040-3061919-040-90- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2020
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?