Home NDC 62135-785 MEXILETINE HYDROCHLORIDE
Product NDC 62135-785
11-digit product format 621350785
Labeler code 62135
Product ID 62135-785_462a5c01-c4ca-6bfa-e063-6294a90a4dd9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mexiletine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA213500
Marketing category ANDA
Marketing start 2020-07-23
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 RLD / RS Approval date A213500-001 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 A213500-002 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 A213500-003 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 114 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 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Observed Orange Book exclusivity history# 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1362720 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-785-90 MEXILETINE HYDROCHLORIDE 90 in 1 BOTTLE CAPSULE 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-785 MEXILETINE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241025_4e03e02f-c516-479e-9126-86b0df7f8b1c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-785-90 62135078590 90 CAPSULE in 1 BOTTLE (62135-785-90) 90 capsule 2023-10-25 No No Current