Mexiletine Hydrochloride

Product NDC: 63629-9290
11-digit product format: 636299290
Labeler code: 63629
Product ID: 63629-9290_bd5bd2a3-e3d8-4183-9e67-0f82da7faba4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mexiletine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074450
Marketing category: ANDA
Marketing start: 2020-06-22
Marketing end: 0000-00-00
Substance: MEXILETINE HYDROCHLORIDE
Active strength: 150 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-9290		D	Discontinued by firm		2026-08-17
excluded package	package	63629-9290	63629-9290-1	D	Discontinued by firm		2026-08-17

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-9290-1	EA - Each	63629-9290	f7df8f6a-0cfc-4939-94e0-29111424ab53	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-9290	MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	102	Legacy NDC	20240116_0cf32b1c-eecd-4270-9cbe-285c7b440d19.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-9290-1	63629929001	100 CAPSULE in 1 BOTTLE (63629-9290-1)	100 capsule	2022-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEXILETINE HYDROCHLORIDE CAPSULES USP	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	102