Mexiletine Hydrochloride

Product NDC: 51407-381
11-digit product format: 514070381
Labeler code: 51407
Product ID: 51407-381_45b6d529-143e-2322-e063-6294a90a65a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mexiletine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA074450
Marketing category: ANDA
Marketing start: 1996-05-16
Substance: MEXILETINE HYDROCHLORIDE
Active strength: 250 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 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
A074450-001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16
A074450-002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16
A074450-003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074450-001	AB
A074450-002	AB
A074450-003	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 4 · 126 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	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074450-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	1996-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074450-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1996-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074450-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	1996-05-16	`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	A074450-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074450-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074450-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074450-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074450-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074450-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074450-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074450-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074450-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074450-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074450-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074450-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074450-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074450-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074450-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074450-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074450-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074450-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074450-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074450-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074450-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074450-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074450-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074450-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074450-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074450-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074450-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074450-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074450-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074450-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074450-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074450-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074450-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074450-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074450-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074450-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074450-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074450-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074450-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074450-001	AB	1	`1e350fbaab3a…`

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	250 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
bfe2b847-e18d-cef2-e053-2995a90a42af	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
51407-381-01	Mexiletine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-381-01	EA - Each	51407-381	d15c82df-50f7-4fb7-a61f-bbfeb92f7954	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-381	MEXILETINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20230325_bfe2b847-e18d-cef2-e053-2995a90a42af.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 · 8 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	c09f68fa-759e-4772-9f6b-11005d8f83d5	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2e1055-2fa1-462c-90f3-6d77e89ea38a	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	b1cb1e35-9586-41c4-b43f-c517f2d42f31	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	8b192b46-e69f-4031-b843-8b28fa85f07b	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	a0bd3f2c-44e5-4ad0-9b76-c2028f0cae11	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	e2c0430d-35ee-460c-b0d5-f117d43430c5	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	bfe2b847-e18d-cef2-e053-2995a90a42af	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450 ndc (product): 51407-381
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	1b3a807f-368a-42dc-8266-ddf8347a8826	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074450 application number: ANDA074450

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	bfe2b847-e18d-cef2-e053-2995a90a42af	3
1362712	mexiletine HCl 200 MG Oral Capsule	PSN	bfe2b847-e18d-cef2-e053-2995a90a42af	3
1362720	mexiletine HCl 250 MG Oral Capsule	PSN	bfe2b847-e18d-cef2-e053-2995a90a42af	3
1362706	mexiletine hydrochloride 150 MG Oral Capsule	SCD	bfe2b847-e18d-cef2-e053-2995a90a42af	3
1362712	mexiletine hydrochloride 200 MG Oral Capsule	SCD	bfe2b847-e18d-cef2-e053-2995a90a42af	3
1362720	mexiletine hydrochloride 250 MG Oral Capsule	SCD	bfe2b847-e18d-cef2-e053-2995a90a42af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-381-01	51407038101	100 CAPSULE in 1 BOTTLE (51407-381-01)	100 capsule	2020-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEXILETINE HYDROCHLORIDE capsule	Golden State Medical Supply, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	3