MEXILETINE HYDROCHLORIDE

Product NDC: 82012-028
11-digit product format: 820120028
Labeler code: 82012
Product ID: 82012-028_dd924d44-b14d-440c-9670-8faa42422ba1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mexiletine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Senores Pharmaceuticals, Inc.
Application: ANDA214089
Marketing category: ANDA
Marketing start: 2021-11-29
Substance: MEXILETINE HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214089-001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01
A214089-002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01
A214089-003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214089-001	AB
A214089-002	AB
A214089-003	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 · 99 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
2026-02-19 14:30 UTC	2026-02	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2021-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214089-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2021-10-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214089-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214089-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214089-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214089-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214089-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214089-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214089-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214089-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214089-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214089-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214089-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214089-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214089-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214089-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214089-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214089-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214089-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: MEXILETINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEXILETINE HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
606D60IS38	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1362706	Internal RxNorm lookup
1362712	Internal RxNorm lookup
1362720	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c4a60f9e-fed1-4172-adc4-0be84ac65db9	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82012-028-04	MEXILETINE HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82012-028	MEXILETINE HYDROCHLORIDE CAPSULE [SENORES PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20230617_c4a60f9e-fed1-4172-adc4-0be84ac65db9.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	3aec79aa-9dfb-495f-9280-2b830dc7eae9	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	68987377-c7c2-493b-be42-30379ec432bc	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	0ff45dbf-b555-4f55-a286-98bfaea9ea29	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	6cd564bd-24e3-481b-b998-f69f65d67fbe	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	2f4239ef-a28a-40d3-9617-2029d492829d	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	9099b620-eae9-48f9-9d5f-8fd22c32b2b0	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	41930321-15e3-4ddf-ba5d-3655ce5f2923	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	217fbd7a-1052-42e4-9e84-70519b7b0b7a	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Senores Pharmaceuticals, Inc.	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089 ndc (product): 82012-028
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	2d0c61ca-4c99-42f9-8f00-e0e9d2672a39	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214089 application number: ANDA214089

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	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2
1362712	mexiletine HCl 200 MG Oral Capsule	PSN	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2
1362720	mexiletine HCl 250 MG Oral Capsule	PSN	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2
1362706	mexiletine hydrochloride 150 MG Oral Capsule	SCD	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2
1362712	mexiletine hydrochloride 200 MG Oral Capsule	SCD	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2
1362720	mexiletine hydrochloride 250 MG Oral Capsule	SCD	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82012-028-04	82012002804	100 CAPSULE in 1 BOTTLE (82012-028-04)	100 capsule	2021-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEXILETINE HYDROCHLORIDE CAPSULES USP, 150 mg, 200 mg and 250 mg	Senores Pharmaceuticals, Inc.	2023-06-16	HUMAN PRESCRIPTION DRUG LABEL	2