Carbamazepine

Treats pain associated with true trigeminal neuralgia. Sold as Tegretol, Tegretol-Xr, Carbatrol, Equetro, Carnexiv. Every FDA application for this active ingredient: 7 branded and 46 generic.

As of Nov 15, 2026, FDA lists 53 applications for Carbamazepine (sold as Tegretol, Tegretol-Xr, Carbatrol and others), first approved Mar 11, 1968, with 7 new uses approved and 0 published complete response letters.

First approved: Mar 11, 1968
Applications: 53
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $121M

Medicare Spending

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


Carbamazepine ER	Part D	$53.4M	-6%	85,940
Carbamazepine	Part D	$39.0M	-2%	130,107
Tegretol XR	Part D	$13.7M	-12%	3,629
Tegretol	Part D	$11.1M	-4%	3,347
Carbatrol	Part D	$3.2M	-2%	1,761
Equetro	Part D	$872K	-17%	336
Epitol	Part D	$40K	-25%	190

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

CARBAMAZEPINE 100 MG TAB CHEW: $0.227 per unitGeneric · -9% in a year
CARBAMAZEPINE 100 MG/5 ML SUSP: $0.089 per MLGeneric · -21% in a year
CARBAMAZEPINE 200 MG TAB CHEW: $1.19 per unitGeneric · new this year
CARBAMAZEPINE 200 MG TABLET: $0.119 per unitGeneric · +1% in a year
CARBAMAZEPINE ER 100 MG CAP: $1.09 per unitGeneric · +0% in a year
CARBAMAZEPINE ER 100 MG TABLET: $0.199 per unitGeneric · -24% in a year
CARBAMAZEPINE ER 200 MG CAP: $1.03 per unitGeneric · -3% in a year
CARBAMAZEPINE ER 200 MG TABLET: $0.379 per unitGeneric · +4% in a year
CARBAMAZEPINE ER 300 MG CAP: $1.13 per unitGeneric · +2% in a year
CARBAMAZEPINE ER 400 MG TABLET: $0.708 per unitGeneric · +0% in a year
TEGRETOL 100 MG/5 ML SUSP: $0.436 per MLBrand · +3% in a year
TEGRETOL 200 MG TABLET: $3.04 per unitBrand · +3% in a year

FDA Drug Safety Communications

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

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseaseMar 31, 2021

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Carbamazepine Capsule, Extended Release	To Be Discontinued	Dec 19, 2025	Dec 19, 2025

Clinical Trials

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


Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot StudyChronic Postsurgical Pain, Chronic Post Cancer Surgery Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre	Phase 2	Recruiting	Nov 5, 2026
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot StudyCancer Pain, Orofacial Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre	Phase 2	Recruiting	Nov 5, 2026
A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult ParticipantsHealthy Adult Participants · GRIN Therapeutics, Inc.	Phase 1	Active, not recruiting	Oct 21, 2026
Prospective Study of Eslicarbazepine in Adults With Focal-Onset SeizuresFocal-Onset Seizures · King Edward Medical University	—	Recruiting	Aug 28, 2026
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Verducatib in the BloodHealthy · Boehringer Ingelheim	Phase 1	Recruiting	Aug 24, 2026
A Trial of Lu AH69593 in Healthy ParticipantsHealthy Participants · H. Lundbeck A/S	Phase 1	Recruiting	Aug 20, 2026
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy ParticipantsHealthy Volunteers · Eisai Inc.	Phase 1	Recruiting	Aug 14, 2026
Clinical Efficacy and Peripheral Ultrasound Mechanism of Trigger Point Bloodletting Therapy for Primary Trigeminal NeuralgiaTrigeminal Neuralgia (TN) · Beijing Hospital of Traditional Chinese Medicine	Not applicable	Not yet recruiting	Aug 6, 2026

Applications

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


Mar 11, 1968	TegretolNDA 16608 · New molecular entity	Novartis	86	Marketed
Dec 14, 1981	TegretolNDA 18281 · New dosage form	Novartis	46	Discontinued
Aug 14, 1986	CarbamazepineANDA 70231	Inwood Labs	8	Discontinued
Sep 17, 1986	EpitolANDA 70541	Teva	52	Discontinued
Jul 24, 1987	CarbamazepineANDA 71479	Pliva	9	Discontinued
Nov 9, 1987	CarbamazepineANDA 71696	Actavis Elizabeth	23	Discontinued
Dec 18, 1987	TegretolNDA 18927 · New dosage form	Novartis	44	Marketed
Feb 1, 1988	CarbamazepineANDA 71940	Jubilant Cadista	10	Discontinued
Jul 29, 1992	EpitolANDA 73524	Teva	28	Marketed
Mar 25, 1996	Tegretol-XrNDA 20234 · New dosage form	Novartis	38	Marketed
Oct 3, 1996	CarbamazepineANDA 74649	Taro	16	Marketed
Sep 30, 1997	CarbatrolNDA 20712 · New dosage form	Takeda Pharms USA	26	Marketed
Oct 24, 2000	CarbamazepineANDA 75687	Taro Pharm Inds	9	Marketed
Dec 21, 2000	CarbamazepineANDA 75875	Taro	0	Discontinued
Jul 5, 2001	CarbamazepineANDA 75712	Torrent Pharms	18	Marketed
Feb 27, 2002	CarbamazepineANDA 75948	Apotex	14	Marketed
Jun 5, 2002	CarbamazepineANDA 75714	Chartwell Rx	7	Marketed
Sep 26, 2003	TerilANDA 76525	Taro	0	Discontinued
Sep 20, 2004	TerilANDA 76729	Taro	7	Marketed
Dec 10, 2004	EquetroNDA 21710 · New dosage form	Validus Pharms	9	Marketed
Dec 7, 2005	CarbamazepineANDA 77272	Torrent Pharms	14	Marketed
Mar 31, 2009	CarbamazepineANDA 78115	Taro	6	Marketed
May 20, 2011	CarbamazepineANDA 76697	Ani Pharms	5	Marketed
Nov 25, 2011	CarbamazepineANDA 78986	Apotex Inc	5	Marketed
Sep 20, 2012	CarbamazepineANDA 78592	Teva Pharms	3	Marketed
Jun 21, 2013	CarbamazepineANDA 201106	Taro	0	Discontinued
Oct 7, 2016	CarnexivNDA 206030 · New dosage form	Lundbeck Pharms LLC	1	Discontinued
Feb 7, 2019	CarbamazepineANDA 205571	Zydus Pharms	3	Marketed
Apr 15, 2020	CarbamazepineANDA 207798	Umedica	2	Marketed
Apr 24, 2020	CarbamazepineANDA 211623	Unique Pharm	1	Marketed
Apr 13, 2021	CarbamazepineANDA 213311	Cspc Ouyi	1	Marketed
Aug 16, 2021	CarbamazepineANDA 214328	Somerset Theraps LLC	0	Discontinued
Sep 30, 2021	CarbamazepineANDA 212948	Anbison Lab	0	Marketed
Mar 31, 2022	CarbamazepineANDA 215591	Zhejiang Jiuzhou	2	Marketed
Aug 18, 2022	CarbamazepineANDA 216594	Umedica	4	Marketed
Aug 22, 2022	CarbamazepineANDA 213284	Unichem	1	Marketed
Oct 6, 2022	CarbamazepineANDA 214277	Novitium Pharma	1	Marketed
Dec 2, 2022	CarbamazepineANDA 216404	Ingenus Pharms LLC	3	Marketed
Mar 2, 2023	CarbamazepineANDA 216235	Sciecure Pharma Inc	0	Marketed
Mar 24, 2023	CarbamazepineANDA 216193	Ajanta Pharma Ltd	1	Discontinued
Sep 22, 2023	CarbamazepineANDA 212704	Amneal Pharms	1	Discontinued
Feb 16, 2024	CarbamazepineANDA 218221	Bionpharma	1	Marketed
Mar 8, 2024	CarbamazepineANDA 213159	Apotex	1	Discontinued
Oct 22, 2024	CarbamazepineANDA 215664	Osmotica Pharm US	0	Discontinued
Jan 13, 2025	CarbamazepineANDA 212524	Torrent	1	Marketed
Jan 14, 2025	CarbamazepineANDA 217277	Alkem Labs Ltd	0	Marketed
Jan 16, 2025	CarbamazepineANDA 219072	Yichang Humanwell	1	Marketed
Apr 16, 2025	CarbamazepineANDA 216623	Alembic	1	Marketed
Jul 25, 2025	CarbamazepineANDA 219939	Alembic	2	Marketed
Nov 2, 2026	CarbamazepineANDA 218447	Adaptis	0	Marketed
—	CarbamazepineANDA 70300	Usl Pharma	0	Discontinued
—	CarbamazepineANDA 70429	Warner Chilcott	0	Discontinued
—	CarbamazepineANDA 78746	Teva Pharms USA	0	Discontinued

Show all 53

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