Tramadol Hydrochloride

Manages severe and persistent pain. Sold as Ultram, Ultram Er, Rybix Odt, Ryzolt, Conzip and 1 more. Every FDA application for this active ingredient: 6 branded and 35 generic.

As of Nov 15, 2026, FDA lists 41 applications for Tramadol Hydrochloride (sold as Ultram, Ultram Er, Rybix Odt and others), first approved Mar 3, 1995, with 3 new uses approved and 0 published complete response letters.

First approved: Mar 3, 1995
Applications: 41
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $121M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Tramadol HCl	Part D	$106M	+20%	4,014,249
Tramadol HCl ER	Part D	$14.6M	-3%	37,564
Conzip	Part D	$31K	-24%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TRAMADOL HCL 100 MG TABLET: $1.10 per unitGeneric · +12% in a year
TRAMADOL HCL 25 MG TABLET: $3.38 per unitGeneric · +4% in a year
TRAMADOL HCL 50 MG TABLET: $0.026 per unitGeneric · +7% in a year
TRAMADOL HCL ER 100 MG CAPSULE: $7.71 per unitGeneric · -1% in a year
TRAMADOL HCL ER 100 MG TABLET: $0.890 per unitGeneric · -18% in a year
TRAMADOL HCL ER 200 MG CAPSULE: $9.85 per unitGeneric · +13% in a year
TRAMADOL HCL ER 200 MG TABLET: $1.39 per unitGeneric · -22% in a year
TRAMADOL HCL ER 300 MG TABLET: $2.07 per unitGeneric · -8% in a year

FDA Drug Safety Communications

2 communications since 2020 that name this drug; see all communications

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

Management of postherpetic neuralgiaTheraQuest Biosciences, LLC · designated Apr 26, 2005
Treatment of painful HIV-associated neuropathyTheraQuest Biosciences, LLC · designated Jan 28, 2005

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

TwotramDrugs with a new indication for analgesia in various types of cancer with pain that cannot be managed by treatment with non-opioid analgesics. · Nippon Zoki Pharmaceutical Co., Ltd. · May 26, 2022
Twotram, new approvalDrugs in a new dosage form indicated for analgesia in chronic pain that cannot be managed by treatment with non-opioid analgesics. · Nippon Zoki Pharmaceutical Co., Ltd. · Sep 25, 2020
Onetram, new approvalA drug in a new dosage form indicated for analgesia in patients with cancers-associated pain or chronic pain, which cannot be managed by treatments with… · Nippon Shinyaku Co., Ltd. · Mar 26, 2015
TramalDrugs with a new additional indication for analgesia in patients with chronic non-cancer pain which cannot be managed by treatments with non-opioid analgesics. · Nippon Shinyaku Co., Ltd. · Jun 14, 2013
Tramal, new approvalDrugs with a new route of administration indicated for analgesia in various types of cancer with mild to moderate pain. · Nippon Shinyaku Co., Ltd. · Jul 23, 2010

Clinical Trials

7 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABGChronic Poststernotomy Pain · Izmir Katip Celebi University	Not applicable	Not yet recruiting	Oct 20, 2026
Nephrostomy Tract Infiltration for Pain Control After PCNLPostoperative Pain, Kidney Calculi · Hitit University	Not applicable	Recruiting	Jul 23, 2026
Comparison of the Analgesic Effects of TFPB in Renal Transplantation SurgeryRenal Transplantation, Peripheral Nerve Block · Ankara Etlik City Hospital	Not applicable	Recruiting	Apr 21, 2026
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active LaborLabor Pain · Universidad Nacional Autonoma de Honduras	Phase 4	Recruiting	Feb 27, 2026
Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval SurgeryOocyte Retrieval for IVF, Pain · First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University	Not applicable	Not yet recruiting	Oct 8, 2025
Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting ConditionsHealthy Volunteer · Haiphong University of Medicine and Pharmacy	Phase 1	Recruiting	Jun 24, 2025
Opioid-Free Pain Protocol After Shoulder ArthroplastyShoulder Arthropathy, Shoulder Pain · Henry Ford Health System	Phase 4	Active, not recruiting	Aug 5, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 3, 1995	UltramNDA 20281 · New molecular entity	Janssen Pharms	35	Discontinued
Jun 19, 2002	Tramadol HydrochlorideANDA 75960	Actavis Elizabeth	3	Discontinued
Jun 19, 2002	Tramadol HydrochlorideANDA 75964	Sun Pharm Inds Inc	17	Marketed
Jun 19, 2002	Tramadol HydrochlorideANDA 75977	Teva	19	Marketed
Jun 20, 2002	Tramadol HydrochlorideANDA 76003	Amneal Pharms	23	Marketed
Jun 20, 2002	Tramadol HydrochlorideANDA 76100	Sun Pharm Industries	9	Discontinued
Jun 21, 2002	Tramadol HydrochlorideANDA 75986	Mylan	6	Discontinued
Jun 24, 2002	Tramadol HydrochlorideANDA 75962	Watson Labs	5	Discontinued
Jun 25, 2002	Tramadol HydrochlorideANDA 75983	Specgx LLC	9	Discontinued
Jun 25, 2002	Tramadol HydrochlorideANDA 75968	Graviti Pharms	11	Marketed
Jul 1, 2002	Tramadol HydrochlorideANDA 75982	Pliva	10	Discontinued
Jul 3, 2002	Tramadol HydrochlorideANDA 75963	Ivax Sub Teva Pharms	0	Discontinued
Jul 10, 2002	Tramadol HydrochlorideANDA 75981	Apotex	18	Discontinued
Jul 12, 2002	Tramadol HydrochlorideANDA 75974	Asta	0	Discontinued
Nov 21, 2002	Tramadol HydrochlorideANDA 75980	Mylan Pharms Inc	3	Discontinued
May 5, 2005	Rybix OdtNDA 21693 · New dosage form	Shionogi Inc	3	Discontinued
Sep 8, 2005	Ultram ErNDA 21692 · New formulation or manufacturer	Valeant Pharms	9	Discontinued
Dec 30, 2008	RyzoltNDA 21745 · New formulation or manufacturer	Purdue Pharma	0	Discontinued
Nov 13, 2009	Tramadol HydrochlorideANDA 78783	Strides Pharma Intl	14	Discontinued
May 7, 2010	ConzipNDA 22370 · New formulation or manufacturer	Cipher Pharms Inc	17	Marketed
May 26, 2010	Tramadol HydrochlorideANDA 78935	Northstar Hlthcare	4	Discontinued
Jan 31, 2011	Tramadol HydrochlorideANDA 90404	Pharmazone	14	Marketed
Aug 29, 2011	Tramadol HydrochlorideANDA 200503	Lupin Ltd	13	Marketed
Nov 28, 2011	Tramadol HydrochlorideANDA 202075	Strides Pharma	8	Marketed
Dec 7, 2011	Tramadol HydrochlorideANDA 201384	Sun Pharm	15	Discontinued
Dec 30, 2011	Tramadol HydrochlorideANDA 91607	Sun Pharm	16	Discontinued
Jun 27, 2012	Tramadol HydrochlorideANDA 91609	Actavis Elizabeth	14	Discontinued
Jun 27, 2012	Tramadol HydrochlorideANDA 200491	Ph Health	13	Discontinued
Nov 16, 2012	Tramadol HydrochlorideANDA 201973	Ipca Labs Ltd	13	Discontinued
Mar 29, 2013	Tramadol HydrochlorideANDA 91498	Cspc Ouyi Pharm Co	14	Marketed
May 16, 2013	Tramadol HydrochlorideANDA 202390	Accord Hlthcare	1	Discontinued
Mar 31, 2014	Tramadol HydrochlorideANDA 203494	Aurobindo Pharma Ltd	15	Marketed
Sep 25, 2015	Tramadol HydrochlorideANDA 205702	Macleods Pharms	14	Discontinued
Oct 20, 2015	Tramadol HydrochlorideANDA 204421	Aurobindo Pharma Ltd	5	Discontinued
Dec 22, 2015	Tramadol HydrochlorideANDA 205257	Mylan	13	Discontinued
Jun 28, 2019	Tramadol HydrochlorideANDA 208708	Rubicon Research	12	Marketed
Jul 2, 2019	Tramadol HydrochlorideANDA 206706	Puracap Labs Blu	3	Discontinued
Aug 9, 2019	Tramadol HydrochlorideANDA 211825	Unichem	10	Marketed
Sep 1, 2020	QdoloNDA 214044 · New dosage form	Rosemont	5	Discontinued
Jan 31, 2025	Tramadol HydrochlorideANDA 209404	Macleods Pharms	2	Marketed
Jun 26, 2026	Tramadol HydrochlorideANDA 219647	Novitium Pharma	0	Marketed

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