Application 074377

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	CAPSULE;ORAL	150MG	No	No
002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	CAPSULE;ORAL	200MG	No	No
003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	CAPSULE;ORAL	250MG	No	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	RLD / RS	Approval date
A074377-001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16
A074377-002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16
A074377-003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074377-001	AB
A074377-002	AB
A074377-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074377-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB		1995-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074377-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	RS	1995-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074377-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB		1995-05-16	`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	A074377-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074377-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074377-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074377-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074377-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074377-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074377-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074377-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074377-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074377-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074377-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074377-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074377-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074377-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074377-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074377-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074377-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074377-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074377-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074377-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074377-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074377-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074377-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074377-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074377-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074377-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074377-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074377-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074377-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074377-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074377-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074377-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074377-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074377-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074377-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074377-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074377-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074377-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074377-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074377-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	AvKARE	c528aae3-ff51-b9e4-a401-4ef5910e4b43	2026-01-15	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 074377 application number: ANDA074377 ndc (product): 42291-624 ndc (product): 42291-626 ndc (product): 42291-625
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	693da40b-26d4-40d6-87d1-158e256f40ab	2022-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074377 application number: ANDA074377 ndc (product): 0093-8739 ndc (product): 0093-8740 ndc (product): 0093-8741

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-8739	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8739	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8740	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8740	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8741	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8741	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-624	Mexiletine Hydrochloride	Mexiletine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-624	Mexiletine Hydrochloride	Mexiletine Hydrochloride	AvKARE	ANDA	Current
42291-625	Mexiletine Hydrochloride	Mexiletine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-625	Mexiletine Hydrochloride	Mexiletine Hydrochloride	AvKARE	ANDA	Current
42291-626	Mexiletine Hydrochloride	Mexiletine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-626	Mexiletine Hydrochloride	Mexiletine Hydrochloride	AvKARE	ANDA	Current
68151-2347	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Carilion Materials Management	ANDA	Current
68151-2985	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Carilion Materials Management	ANDA	Current
68151-2986	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Carilion Materials Management	ANDA	Current