Mexiletine Hydrochloride

Product NDC: 71335-3171
Requested package NDC: 71335-3171-2
11-digit product format: 713353171
Labeler code: 71335
Product ID: 71335-3171_0c0375ea-6209-4efb-acdd-ab3a0860e07c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mexiletine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA215315
Marketing category: ANDA
Marketing start: 2025-02-05
Substance: MEXILETINE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215315-001	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26
A215315-002	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26
A215315-003	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215315-001	AB
A215315-002	AB
A215315-003	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 · 87 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
2026-09-14 22:38:34	2026-08	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215315-002	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE / ORAL	AB	2022-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215315-003	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2022-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215315-001	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE / ORAL	AB	2022-08-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215315-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215315-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215315-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215315-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215315-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215315-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215315-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215315-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215315-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215315-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215315-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215315-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215315-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215315-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215315-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215315-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215315-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215315-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215315-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215315-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215315-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215315-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215315-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215315-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215315-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215315-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215315-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215315-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215315-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215315-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215315-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215315-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215315-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215315-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215315-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215315-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215315-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215315-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215315-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215315-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mexiletine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEXILETINE HYDROCHLORIDE	150 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1362706	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
1c6024e9-760b-40a4-9ef1-b75b269c582a	Available on FDA.report

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	Bryant Ranch Prepack	1c6024e9-760b-40a4-9ef1-b75b269c582a	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215315 application number: ANDA215315 ndc (package): 71335-3171-2 ndc (product): 71335-3171 ndc11 (package): 71335317102
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	17c65cba-f56f-4cad-a9e2-d31f62e95849	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215315 application number: ANDA215315

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	Sample	Exclude flag	Status
71335-3171-2	71335317102	270 CAPSULE in 1 BOTTLE (71335-3171-2)	270 capsule	2026-08-11	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 Rx only	Bryant Ranch Prepack	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	1