Naproxen Sodium

Relieves mild to moderate pain. Sold as Anaprox, Anaprox Ds, Aleve, Naprelan, Naproxen Sodium. Every FDA application for this active ingredient: 4 branded and 39 generic.

As of Nov 15, 2026, FDA lists 43 applications for Naproxen Sodium (sold as Anaprox, Anaprox Ds, Aleve and others), first approved Sep 4, 1980, with 2 new uses approved and 0 published complete response letters.

First approved: Sep 4, 1980
Applications: 43
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $5.1M

Medicare Spending

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


Naproxen Sodium	Part D	$2.2M	-22%	35,038
Naproxen Sodium ER	Part D	$2.1M	+12%	1,092
Naproxen Sodium Cr	Part D	$838K	-28%	620
Naprelan	Part D	$35K	-49%	11

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

NAPROXEN 125 MG/5 ML SUSPEN: $0.209 per MLGeneric · -11% in a year
NAPROXEN 250 MG TABLET: $0.049 per unitGeneric · +9% in a year
NAPROXEN 375 MG TABLET: $0.058 per unitGeneric · -2% in a year
NAPROXEN 500 MG TABLET: $0.058 per unitGeneric · -8% in a year
NAPROXEN DR 375 MG TABLET: $2.16 per unitGeneric · +70% in a year
NAPROXEN DR 500 MG TABLET: $1.95 per unitGeneric · -9% in a year
NAPROXEN SODIUM 275 MG TAB: $0.196 per unitGeneric · -41% in a year
NAPROXEN SODIUM 550 MG TAB: $0.215 per unitGeneric · -5% in a year

FDA Drug Safety Communications

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

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluidOct 15, 2020

Clinical Trials

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


Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi AnemiaFanconi Anemia, Head and Neck Cancer · Rockefeller University	Phase 1	Recruiting	Oct 28, 2026
Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill QuantityOpioid Abuse (Disorder), Opioid Analgesia · AdventHealth	Phase 4	Enrolling by invitation	Aug 6, 2026
NSAIDS Following Elective Lumbar Spine FusionNSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion · Rothman Institute Orthopaedics	Phase 3	Enrolling by invitation	Aug 4, 2026
Clinical and Economic Evaluation of Point-of-care Ultrasound-guided Infiltration for Subacromial and Carpal Tunnel Syndromes in Primary Care: a Cluster-randomized Study Protocol.Subacromial Impingement Syndrome, Carpal Tunnel Syndrome (CTS) · Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Phase 4	Active, not recruiting	Jul 9, 2026
Naproxen Versus Placebo as Adjunct Treatment of CellulitisCellulitis, Skin Disease, Infectious · Ottawa Hospital Research Institute	Phase 3	Not yet recruiting	Jun 24, 2026
Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer PatientsOral Cancer, Oral Cavity Cancer · Mayo Hospital Lahore	Not applicable	Enrolling by invitation	May 26, 2026
Human Experimental Models of Pain (HEMP)Acute Pain · National Center for Complementary and Integrative Health (NCCIH)	Not applicable	Not yet recruiting	Apr 24, 2026
The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device InsertionPain During Intrauterine Device Insertion · Monakshi Sawhney	Phase 4	Not yet recruiting	Apr 22, 2026

Applications

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


Sep 4, 1980	Anaprox, Anaprox DsNDA 18164 · New formulation or manufacturer	Atnahs Pharma US	50	Marketed
Aug 31, 1993	Naproxen SodiumANDA 74106	Hamilton Pharms	1	Discontinued
Dec 21, 1993	Naproxen SodiumANDA 74162	Sandoz	16	Discontinued
Dec 21, 1993	Naproxen SodiumANDA 74195	Watson Labs	7	Discontinued
Dec 21, 1993	Naproxen SodiumANDA 74198	Teva	20	Discontinued
Dec 21, 1993	Naproxen SodiumANDA 74257	Roxane	2	Discontinued
Dec 21, 1993	Naproxen SodiumANDA 74142	Teva	10	Discontinued
Jan 11, 1994	AleveNDA 20204 · New dosage form	Bayer	63	Marketed
Jan 27, 1994	Naproxen SodiumANDA 74289	Teva Pharms	7	Discontinued
Aug 31, 1994	Naproxen SodiumANDA 74367	Pharmobedient	9	Discontinued
Dec 5, 1994	Naproxen SodiumANDA 74495	Sandoz	11	Discontinued
Mar 14, 1995	Naproxen SodiumANDA 74230	Ivax Sub Teva Pharms	3	Discontinued
May 31, 1995	Naproxen SodiumANDA 74455	Watson Labs	5	Discontinued
Jan 5, 1996	NaprelanNDA 20353 · New dosage form	Twi Pharms	24	Marketed
May 14, 1996	Naproxen SodiumANDA 74480	Hikma	20	Discontinued
Jun 20, 1996	Naproxen SodiumANDA 74242	Pliva	1	Discontinued
Jan 13, 1997	Naproxen SodiumANDA 74661	Perrigo	15	Marketed
Jan 13, 1997	Naproxen SodiumANDA 74635	Contract Pharmacal	14	Marketed
Jan 13, 1997	Naproxen SodiumANDA 74646	Pld Acquisitions LLC	2	Discontinued
Feb 27, 1997	Naproxen SodiumANDA 74789	Contract Pharmacal	4	Discontinued
Jul 28, 1998	Naproxen SodiumANDA 75168	Dr Reddys Labs Inc	3	Marketed
Aug 27, 2002	Naproxen SodiumANDA 75416	Actavis Labs Fl Inc	10	Marketed
Aug 22, 2003	Naproxen SodiumANDA 76544	Able	0	Discontinued
Feb 17, 2006	Naproxen SodiumNDA 21920 · New dosage form	Bionpharma	15	Marketed
Apr 25, 2007	Naproxen SodiumANDA 78432	Amneal Pharms Ny	8	Discontinued
Apr 27, 2007	Naproxen SodiumANDA 78314	Glenmark Pharms Ltd	5	Marketed
Jul 26, 2007	Naproxen SodiumANDA 78486	Dr Reddys Labs Ltd	8	Marketed
Dec 16, 2008	Naproxen SodiumANDA 79096	Amneal Pharms Ny	4	Marketed
Mar 16, 2011	Naproxen SodiumANDA 90545	Pharmazone	3	Marketed
May 20, 2011	Naproxen SodiumANDA 91183	Sun Pharm Inds Ltd	0	Discontinued
Sep 20, 2011	Naproxen SodiumANDA 91353	Granules India	7	Marketed
Oct 31, 2011	Naproxen SodiumANDA 200629	Aurobindo Pharma Ltd	7	Marketed
Mar 18, 2016	Naproxen SodiumANDA 205497	Aurobindo Pharma Ltd	0	Marketed
Jan 23, 2017	Naproxen SodiumANDA 204872	Lnk Intl Inc	5	Marketed
Mar 15, 2018	Naproxen SodiumANDA 208363	Puracap Pharm LLC	1	Marketed
Nov 16, 2018	Naproxen SodiumANDA 207612	Novelgenix Theraps	0	Discontinued
Jan 4, 2019	Naproxen SodiumANDA 202807	Catalent	4	Marketed
Aug 30, 2019	Naproxen SodiumANDA 212033	Yichang Humanwell	1	Marketed
Oct 30, 2019	Naproxen SodiumANDA 212199	Sciegen Pharms	2	Marketed
Aug 17, 2022	Naproxen SodiumANDA 215472	Onesource	0	Discontinued
Oct 28, 2022	Naproxen SodiumANDA 211065	Hetero Labs Ltd V	0	Marketed
Jan 10, 2023	Naproxen SodiumANDA 214463	Patheon Softgels	1	Marketed
—	Naproxen SodiumANDA 74319	Purepac Pharm	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