Application 074450

Type: ANDA
Sponsor: ANI PHARMS INC

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	No

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…`

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 ndc (product): 63629-2145
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 ndc (product): 63629-1963
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 ndc (product): 63629-1964
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): 51407-380 ndc (product): 51407-379 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 ndc (product): 62559-821 ndc (product): 62559-822 ndc (product): 62559-820

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-379	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-380	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-381	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
62559-820	Mexiletine Hydrochloride	Mexiletine Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-821	Mexiletine Hydrochloride	Mexiletine Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-822	Mexiletine Hydrochloride	Mexiletine Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1962	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1963	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1963	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1964	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1964	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2145	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2145	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9290	Mexiletine Hydrochloride	Mexiletine Hydrochloride	Bryant Ranch Prepack	ANDA	Current