Sold as Zantac 150, Zantac 300, Zantac, Zantac In Plastic Container, Zantac 25 and 1 more. Every FDA application for this active ingredient: 9 branded and 75 generic.
As of Nov 15, 2026, FDA lists 84 applications for Ranitidine Hydrochloride (sold as Zantac 150, Zantac 300, Zantac and others), first approved Jun 9, 1983, with 13 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Ranitidine HCl | Part D | $0K | New | 0 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| : Vascular Function in Health and DiseaseChronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension · D. Walter Wray | Phase 1 | Recruiting | Nov 17, 2016 |
| Jun 9, 1983 | Zantac 150, Zantac 300NDA 18703 · New molecular entity | Glaxo Grp Ltd | 61 | Discontinued |
| Oct 19, 1984 | ZantacNDA 19090 · New dosage form | Pai Holdings Pharm | 43 | Discontinued |
| Dec 17, 1986 | Zantac In Plastic ContainerNDA 19593 · New dosage form | Pai Holdings Pharm | 32 | Discontinued |
| Dec 30, 1988 | ZantacNDA 19675 · New dosage form | Glaxo Grp Ltd | 29 | Discontinued |
| Mar 8, 1994 | Zantac 150, Zantac 300NDA 20095 · New dosage form | Glaxosmithkline | 13 | Discontinued |
| Mar 31, 1994 | Zantac 150, Zantac 25NDA 20251 · New dosage form | Glaxo Grp Ltd | 16 | Discontinued |
| Dec 19, 1995 | Zantac 75NDA 20520 · New dosage form | Chattem Sanofi | 20 | Discontinued |
| Jul 31, 1997 | Ranitidine HydrochlorideANDA 74488 | Ani Pharms | 19 | Discontinued |
| Aug 22, 1997 | Ranitidine HydrochlorideANDA 74023 | Mylan | 12 | Discontinued |
| Aug 29, 1997 | Ranitidine HydrochlorideANDA 74467 | Sandoz | 25 | Marketed |
| Aug 29, 1997 | Ranitidine HydrochlorideANDA 74662 | Boehringer Ingelheim | 0 | Discontinued |
| Sep 12, 1997 | Ranitidine HydrochlorideANDA 74680 | Apotex | 5 | Discontinued |
| Oct 20, 1997 | Ranitidine HydrochlorideANDA 74864 | Watson Labs | 6 | Discontinued |
| Oct 22, 1997 | Ranitidine HydrochlorideANDA 74655 | Sandoz | 16 | Marketed |
| Jan 30, 1998 | Ranitidine HydrochlorideANDA 75000 | Ranbaxy | 2 | Discontinued |
| Feb 26, 1998 | Zantac 75NDA 20745 · New dosage form | Chattem Sanofi | 1 | Discontinued |
| Jul 30, 1998 | Ranitidine HydrochlorideANDA 74552 | Pharmobedient | 0 | Discontinued |
| Sep 30, 1998 | Ranitidine HydrochlorideANDA 75165 | Heritage Pharma Avet | 3 | Discontinued |
| Dec 17, 1998 | Ranitidine HydrochlorideANDA 75208 | Wockhardt Ltd | 4 | Discontinued |
| Jan 28, 1999 | Ranitidine HydrochlorideANDA 75180 | Ph Health | 5 | Discontinued |
| Jun 21, 1999 | Ranitidine HydrochlorideANDA 75094 | Contract Pharmacal | 2 | Discontinued |
| Jan 14, 2000 | Ranitidine HydrochlorideANDA 75212 | Ani Pharms | 0 | Discontinued |
| Jan 14, 2000 | Ranitidine HydrochlorideANDA 75254 | Ranbaxy | 0 | Discontinued |
| Jan 14, 2000 | Ranitidine HydrochlorideANDA 75296 | Ani Pharms | 7 | Discontinued |
| Jan 14, 2000 | Ranitidine HydrochlorideANDA 75497 | Rising | 3 | Discontinued |
| Jan 14, 2000 | Ranitidine HydrochlorideANDA 75132 | Sun Pharm Inds Ltd | 13 | Discontinued |
| Mar 28, 2000 | Ranitidine HydrochlorideANDA 75294 | Dr Reddys Labs Ltd | 18 | Marketed |
| Apr 19, 2000 | Ranitidine HydrochlorideANDA 75439 | Sun Pharm Inds Ltd | 6 | Discontinued |
| May 4, 2000 | Ranitidine HydrochlorideANDA 75167 | Apotex | 3 | Discontinued |
| Oct 27, 2000 | Ranitidine HydrochlorideANDA 75564 | Rising | 1 | Discontinued |
| Nov 29, 2000 | Ranitidine HydrochlorideANDA 75742 | Dr Reddys Labs Ltd | 1 | Marketed |
| Aug 30, 2002 | Ranitidine HydrochlorideANDA 76195 | Perrigo | 4 | Discontinued |
| Sep 26, 2002 | Ranitidine HydrochlorideANDA 75519 | Sandoz | 0 | Discontinued |
| Oct 31, 2003 | Ranitidine HydrochlorideANDA 75557 | Teva | 0 | Discontinued |
| Aug 31, 2004 | Zantac 150NDA 21698 · New dosage form | Chattem Sanofi | 10 | Discontinued |
| Nov 19, 2004 | Ranitidine HydrochlorideANDA 74764 | Bedford | 0 | Discontinued |
| Mar 2, 2005 | Ranitidine HydrochlorideANDA 74777 | Hikma | 3 | Discontinued |
| Jul 27, 2005 | Ranitidine HydrochlorideANDA 76705 | Dr Reddys Labs Inc | 3 | Marketed |
| Dec 19, 2005 | Ranitidine HydrochlorideANDA 77426 | Ani Pharms | 1 | Discontinued |
| Feb 16, 2006 | Ranitidine HydrochlorideANDA 77458 | Hikma | 2 | Discontinued |
| Feb 24, 2006 | Ranitidine HydrochlorideANDA 76760 | Wockhardt | 0 | Discontinued |
| Oct 13, 2006 | Ranitidine HydrochlorideANDA 77824 | Amneal Pharms Ny | 3 | Discontinued |
| Feb 21, 2007 | Ranitidine HydrochlorideANDA 76124 | Actavis Mid Atlantic | 0 | Discontinued |
| Aug 31, 2007 | Ranitidine HydrochlorideANDA 78192 | Dr Reddys Labs Ltd | 2 | Marketed |
| Sep 17, 2007 | Ranitidine HydrochlorideANDA 77602 | Apotex Inc | 1 | Discontinued |
| Sep 21, 2007 | Ranitidine HydrochlorideANDA 77405 | Pharm Assoc | 3 | Discontinued |
| Nov 26, 2007 | Ranitidine HydrochlorideANDA 78653 | Wockhardt | 1 | Discontinued |
| Dec 13, 2007 | Ranitidine HydrochlorideANDA 78448 | Ranbaxy | 0 | Discontinued |
| Jul 31, 2008 | Ranitidine HydrochlorideANDA 78884 | Wockhardt | 1 | Discontinued |
| Sep 2, 2008 | Ranitidine HydrochlorideANDA 78312 | Amneal Pharms | 1 | Discontinued |
| Nov 19, 2008 | Ranitidine HydrochlorideANDA 78542 | Glenmark Pharms | 2 | Discontinued |
| Feb 23, 2009 | Ranitidine HydrochlorideANDA 79212 | Wockhardt | 0 | Discontinued |
| May 26, 2009 | Ranitidine HydrochlorideANDA 79211 | Wockhardt | 1 | Discontinued |
| May 26, 2009 | Ranitidine HydrochlorideANDA 90102 | Torrent | 1 | Discontinued |
| Aug 27, 2009 | Ranitidine HydrochlorideANDA 78684 | Nostrum Labs Inc | 0 | Discontinued |
| Dec 11, 2009 | Ranitidine HydrochlorideANDA 78701 | Wockhardt | 1 | Discontinued |
| Jul 1, 2010 | Ranitidine HydrochlorideANDA 78890 | Lannett Co Inc | 0 | Discontinued |
| Jul 28, 2010 | Ranitidine HydrochlorideANDA 90623 | Aurobindo Pharma | 0 | Discontinued |
| Nov 15, 2010 | Ranitidine HydrochlorideANDA 90054 | Tolmar | 0 | Discontinued |
| Dec 9, 2010 | Ranitidine HydrochlorideANDA 91288 | Lannett Co Inc | 0 | Discontinued |
| Mar 22, 2011 | Ranitidine HydrochlorideANDA 91078 | Epic Pharma LLC | 1 | Discontinued |
| May 11, 2011 | Ranitidine HydrochlorideANDA 91429 | Perrigo R And D | 0 | Discontinued |
| Jun 13, 2011 | Ranitidine HydrochlorideANDA 77476 | Sun Pharma Canada | 0 | Discontinued |
| Jun 28, 2011 | Ranitidine HydrochlorideANDA 200536 | Strides Pharma | 1 | Discontinued |
| Sep 20, 2011 | Ranitidine HydrochlorideANDA 91091 | Nostrum Labs Inc | 0 | Discontinued |
| Feb 29, 2012 | Ranitidine HydrochlorideANDA 201745 | Strides Pharma | 0 | Discontinued |
| May 31, 2012 | Ranitidine HydrochlorideANDA 200172 | Apotex Inc | 1 | Discontinued |
| Feb 22, 2013 | Ranitidine HydrochlorideANDA 91534 | Zydus Pharms USA Inc | 1 | Discontinued |
| Jun 9, 2016 | Ranitidine HydrochlorideANDA 79076 | Mylan Labs Ltd | 0 | Discontinued |
| Aug 22, 2016 | Ranitidine HydrochlorideANDA 205512 | Strides Pharma | 1 | Discontinued |
| Nov 13, 2017 | Ranitidine HydrochlorideANDA 207578 | Aurobindo Pharma | 0 | Discontinued |
| Nov 13, 2017 | Ranitidine HydrochlorideANDA 207579 | Aurobindo Pharma | 0 | Discontinued |
| Nov 30, 2017 | Ranitidine HydrochlorideANDA 203694 | Mpp Pharma | 0 | Discontinued |
| Feb 22, 2018 | Ranitidine HydrochlorideANDA 209161 | Strides Pharma | 2 | Discontinued |
| Mar 5, 2018 | Ranitidine HydrochlorideANDA 209160 | Strides Pharma | 0 | Discontinued |
| Jul 16, 2018 | Ranitidine HydrochlorideANDA 211058 | Aurobindo Pharma | 0 | Discontinued |
| Aug 1, 2018 | Ranitidine HydrochlorideANDA 210010 | Strides Pharma | 0 | Discontinued |
| Aug 20, 2018 | Ranitidine HydrochlorideANDA 210243 | Granules | 0 | Discontinued |
| Sep 27, 2018 | Ranitidine HydrochlorideANDA 209859 | Ajanta Pharma Ltd | 0 | Discontinued |
| Nov 23, 2018 | Ranitidine HydrochlorideANDA 210681 | Novitium Pharma | 0 | Discontinued |
| Jan 31, 2019 | Ranitidine HydrochlorideANDA 211289 | Vkt Pharma | 1 | Marketed |
| Apr 5, 2019 | Ranitidine HydrochlorideANDA 211893 | Appco | 0 | Discontinued |
| Aug 30, 2019 | Ranitidine HydrochlorideANDA 210228 | Thinq Pharm-Cro Pvt | 0 | Discontinued |
| Aug 30, 2019 | Ranitidine HydrochlorideANDA 210250 | Thinq Pharm-Cro Pvt | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Glaxosmithkline
Mylan
Sandoz
Boehringer Ingelheim
Apotex
Sun Pharm Inds Ltd
Perrigo
Teva
Hikma
Wockhardt
Aurobindo Pharma
Strides Pharma
Zydus Pharms USA Inc
Novitium Pharma