Home NDC 42291-624 Mexiletine Hydrochloride
Product NDC 42291-624
11-digit product format 422910624
Labeler code 42291
Product ID 42291-624_4870f872-0804-7f08-e063-6394a90a19e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mexiletine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA074377
Marketing category ANDA
Marketing start 2013-07-09
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 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.
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.
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1362706 Internal RxNorm lookup 1362712 Internal RxNorm lookup 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 42291-624-01 Mexiletine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEXILETINE HYDROCHLORIDE ACTIVE INGREDIENT 606D60IS38 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 MEXILETINE ACTIVE MOIETY 1U511HHV4Z MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-624 MEXILETINE HYDROCHLORIDE CAPSULE [AVKARE] 8 Current NDC, Legacy NDC, 1 package rows 20230511_c528aae3-ff51-b9e4-a401-4ef5910e4b43.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-624-01 42291062401 100 CAPSULE in 1 BOTTLE (42291-624-01) 100 capsule 2013-07-09 0000-00-00 No No Current