Alprazolam

Treats panic disorder with or without agoraphobia. Sold as Xanax, Xanax Xr, Niravam. Every FDA application for this active ingredient: 3 branded and 37 generic.

As of Nov 14, 2026, FDA lists 40 applications for Alprazolam (sold as Xanax, Xanax Xr, Niravam), first approved Oct 16, 1981, with 1 new use approved and 0 published complete response letters.

First approved: Oct 16, 1981
Applications: 40
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $102M

Medicare Spending

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


Alprazolam	Part D	$86.9M	+43%	2,294,755
Xanax	Part D	$12.7M	-5%	3,073
Alprazolam ER	Part D	$1.5M	-16%	10,546
Alprazolam ODT	Part D	$601K	+7%	3,919
Alprazolam XR	Part D	$380K	-21%	3,554
Xanax XR	Part D	$188K	-15%	42
Alprazolam Intensol	Part D	$47K	+3%	175

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

ALPRAZOLAM 0.25 MG TABLET: $0.023 per unitGeneric · -4% in a year
ALPRAZOLAM 0.5 MG TABLET: $0.023 per unitGeneric · -3% in a year
ALPRAZOLAM 1 MG TABLET: $0.025 per unitGeneric · -3% in a year
ALPRAZOLAM 2 MG TABLET: $0.048 per unitGeneric · -2% in a year
ALPRAZOLAM ER 0.5 MG TABLET: $0.150 per unitGeneric · -10% in a year
ALPRAZOLAM ER 1 MG TABLET: $0.153 per unitGeneric · -16% in a year
ALPRAZOLAM ER 2 MG TABLET: $0.213 per unitGeneric · 0% in a year
ALPRAZOLAM ER 3 MG TABLET: $0.247 per unitGeneric · -20% in a year
ALPRAZOLAM ODT 0.25 MG TAB: $0.965 per unitGeneric · -4% in a year
ALPRAZOLAM ODT 0.5 MG TAB: $1.24 per unitGeneric · -6% in a year
ALPRAZOLAM ODT 1 MG TAB: $1.77 per unitGeneric · +2% in a year
XANAX 0.25 MG TABLET: $5.63 per unitBrand · +5% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug classSep 23, 2020 · boxed warning

Clinical Trials

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


Effect of IE Glasses on MRI Patient OutcomesMRI-related Anxiety, MRI Completion Rate · Baptist Health South Florida	Not applicable	Not yet recruiting	Jun 22, 2026
Role of Alprazolam in Management of Post Endodontic Pain After Single Visit Root Canal Treatment. To Compare Mean Pain Score Between Two Group of Participants Undergoing Post Operative Pain Management After Single Visit Root Canal Treatment: NSAIDs Alone and a Combination of NSAIDs and Alprazolam.Pain · Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi	Not applicable	Recruiting	Dec 10, 2025
An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain SatisfactionOphthalmology, Cataract Surgery Anesthesia · National Taiwan University Hospital	Phase 4	Recruiting	Mar 13, 2025
Anxiety and Surgery Satisfaction for Cataract Patient With Different State AnxietyOral Anxiolytic, Phacoemulsification · National Taiwan University Hospital	Not applicable	Recruiting	Feb 14, 2025
Opioid Drug Interaction StudyDrug Interactions, Drug Kinetics · Shanna Babalonis, PhD	Phase 1 / Phase 2	Recruiting	Jan 3, 2025
Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential TremorEssential Tremor · The Cleveland Clinic	—	Recruiting	Mar 5, 2024
Efficacy of Hydroxyzine for Patients With Panic DisorderPanic Disorder · Sultan Qaboos University	Phase 4	Not yet recruiting	Feb 21, 2023
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged SeizuresStereotypical Prolonged Seizures · UCB Biopharma SRL	Phase 3	Recruiting	Oct 14, 2021

Applications

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


Oct 16, 1981	XanaxNDA 18276 · New molecular entity	Upjohn	39	Marketed
Oct 19, 1993	AlprazolamANDA 74046	Pharmobedient	5	Discontinued
Oct 19, 1993	AlprazolamANDA 74174	Novitium Pharma	6	Marketed
Oct 31, 1993	AlprazolamANDA 74312	Hikma	10	Marketed
Oct 31, 1993	AlprazolamANDA 74314	Roxane	0	Discontinued
Oct 31, 1993	AlprazolamANDA 74342	Actavis Elizabeth	16	Marketed
Jan 27, 1994	AlprazolamANDA 74215	Mylan	11	Discontinued
Feb 16, 1994	AlprazolamANDA 74085	Ani Pharms	6	Discontinued
Jul 29, 1994	AlprazolamANDA 74294	Ivax Sub Teva Pharms	1	Discontinued
Aug 31, 1995	AlprazolamANDA 74456	Watson Labs	3	Discontinued
Dec 29, 1995	AlprazolamANDA 74112	Sandoz	21	Marketed
Jan 21, 1997	AlprazolamANDA 74479	Watson Labs	8	Discontinued
Mar 25, 1998	AlprazolamANDA 74909	Sandoz	14	Marketed
Jan 17, 2003	Xanax XrNDA 21434 · New dosage form	Upjohn	9	Marketed
Jan 19, 2005	NiravamNDA 21726 · New dosage form	Ucb Inc	3	Discontinued
Jan 26, 2006	AlprazolamANDA 77391	Pharmobedient	3	Discontinued
Jun 30, 2006	AlprazolamANDA 77777	Sandoz Inc	3	Discontinued
Jul 31, 2006	AlprazolamANDA 77725	Ani Pharms	0	Discontinued
Jan 19, 2007	AlprazolamANDA 77741	Apotex Inc	4	Discontinued
Jan 31, 2007	AlprazolamANDA 77996	Impax Labs Inc	1	Discontinued
Feb 13, 2007	AlprazolamANDA 78056	Actavis Elizabeth	4	Discontinued
Feb 28, 2007	AlprazolamANDA 77979	Ani Pharms	0	Discontinued
May 24, 2007	AlprazolamANDA 77968	Impax Labs	0	Discontinued
Oct 15, 2007	AlprazolamANDA 78442	Ph Health	1	Discontinued
May 30, 2008	AlprazolamANDA 78387	Amneal Pharms Ny	4	Marketed
Sep 25, 2008	AlprazolamANDA 78491	Tp Anda Holdings	3	Discontinued
Oct 17, 2008	AlprazolamANDA 78489	Heritage Pharms Inc	0	Discontinued
Nov 12, 2008	AlprazolamANDA 78449	Apotex Inc	6	Discontinued
Jan 9, 2009	AlprazolamANDA 78088	Ph Health	5	Marketed
Mar 16, 2010	AlprazolamANDA 78561	Actavis Elizabeth	6	Marketed
May 13, 2010	AlprazolamANDA 77198	Actavis Labs Fl Inc	0	Discontinued
Jun 17, 2010	AlprazolamANDA 90082	Sun Pharm	1	Discontinued
Sep 17, 2010	AlprazolamANDA 90248	Strides Pharma Intl	4	Discontinued
Jun 7, 2011	AlprazolamANDA 90871	Aurobindo Pharma	6	Marketed
Sep 29, 2011	AlprazolamANDA 78469	Ph Health	0	Discontinued
Apr 15, 2015	AlprazolamANDA 200739	Natco	1	Marketed
Jul 31, 2015	AlprazolamANDA 203346	Aurobindo Pharma	4	Marketed
Jul 9, 2018	AlprazolamANDA 207507	Chartwell Rx	2	Discontinued
Jul 13, 2026	AlprazolamANDA 213204	Unichem	0	Marketed
—	AlprazolamANDA 74199	Roxane	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