Mexiletine Hydrochloride

Product NDC: 10135-731
Requested package NDC: 10135-731-01
11-digit product format: 101350731
Labeler code: 10135
Product ID: 10135-731_d7dc41b7-6d65-1693-e053-2a95a90a70d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mexiletine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc.
Application: ANDA213500
Marketing category: ANDA
Marketing start: 2022-02-01
Marketing end: 0000-00-00
Substance: MEXILETINE HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10135-731	10135-731-01	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213500-001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22
A213500-002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22
A213500-003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213500-001	AB
A213500-002	AB
A213500-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213500-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2020-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213500-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213500-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2020-07-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213500-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213500-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213500-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213500-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213500-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213500-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213500-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213500-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213500-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213500-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213500-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213500-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213500-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213500-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213500-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213500-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213500-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213500-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213500-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213500-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213500-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213500-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213500-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213500-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213500-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213500-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213500-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213500-001	AB	1	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213500-001	CGT	2021-01-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213500-002	CGT	2021-01-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213500-003	CGT	2021-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213500-001	CGT	2021-01-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213500-002	CGT	2021-01-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213500-003	CGT	2021-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213500-001	CGT	2021-01-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213500-002	CGT	2021-01-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213500-003	CGT	2021-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213500-001	CGT	2021-01-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213500-002	CGT	2021-01-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213500-003	CGT	2021-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213500-001	CGT	2021-01-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213500-002	CGT	2021-01-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213500-003	CGT	2021-01-18	`c0c555d07b60…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
497452b0-11f5-0347-7928-e7d06bb38077	Product name	4	20230426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-731-01	2025-01-30	C162847	48780-1	2cef2736-97fc-d83d-e063-dadaa90ab31f	MEXILETINE HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-731-01	Mexiletine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-731-01	EA - Each	10135-731	9c800e24-27f6-4872-a176-cce55db26806	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-731	MEXILETINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS, INC.]	2	Legacy NDC, 1 package rows	20231110_d7dc41b7-6d64-1693-e053-2a95a90a70d4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Chartwell RX, LLC	4e03e02f-c516-479e-9126-86b0df7f8b1c	2025-12-17	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 213500 application number: ANDA213500

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
606D60IS38	MEXILETINE HYDROCHLORIDE	5370-01-4	MEXILETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1362706	mexiletine HCl 150 MG Oral Capsule	PSN	d7dc41b7-6d64-1693-e053-2a95a90a70d4	2
1362712	mexiletine HCl 200 MG Oral Capsule	PSN	d7dc41b7-6d64-1693-e053-2a95a90a70d4	2
1362720	mexiletine HCl 250 MG Oral Capsule	PSN	d7dc41b7-6d64-1693-e053-2a95a90a70d4	2
1362706	mexiletine hydrochloride 150 MG Oral Capsule	SCD	d7dc41b7-6d64-1693-e053-2a95a90a70d4	2
1362712	mexiletine hydrochloride 200 MG Oral Capsule	SCD	d7dc41b7-6d64-1693-e053-2a95a90a70d4	2
1362720	mexiletine hydrochloride 250 MG Oral Capsule	SCD	d7dc41b7-6d64-1693-e053-2a95a90a70d4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-731-01	10135073101	100 CAPSULE in 1 BOTTLE (10135-731-01)	100 capsule	2022-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEXILETINE HYDROCHLORIDE CAPSULES, USP	Marlex Pharmaceuticals, Inc.	2023-11-09	HUMAN PRESCRIPTION DRUG LABEL	2