Mexiletine Hydrochloride

Product NDC
0093-8741
11-digit product format
000938741
Labeler code
0093
Product ID
0093-8741_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074377
Marketing category
ANDA
Marketing start
1995-06-05
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct0093-8741UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0093-87410093-8741-99UNFINISHEDActive or certified unfinished drug listing2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0093-8741-99a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0093-8741-991d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0093-8741-99390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0093-8741-99e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0093-8741-99bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0093-8741-99f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0093-8741-99f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0093-8741-9968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0093-8741-9905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage0093-8741-9948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage0093-8741-9927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage0093-8741-998d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage0093-8741-99d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage0093-8741-9950b4072663b7…eae3003ed65e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074377-001MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16
A074377-002MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16
A074377-003MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074377-001AB
A074377-002AB
A074377-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074377-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB1995-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074377-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALABRS1995-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074377-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB1995-05-161e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074377-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074377-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074377-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074377-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074377-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074377-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074377-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074377-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074377-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074377-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074377-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074377-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074377-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074377-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074377-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074377-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074377-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074377-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074377-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074377-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074377-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074377-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074377-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074377-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074377-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074377-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074377-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074377-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074377-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074377-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074377-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074377-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074377-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074377-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074377-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074377-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074377-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074377-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074377-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074377-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Mexiletine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEXILETINE HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
606D60IS38Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1362706Internal RxNorm lookup
1362712Internal RxNorm lookup
1362720Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
693da40b-26d4-40d6-87d1-158e256f40abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
497452b0-11f5-0347-7928-e7d06bb38077Product name420230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-8741-01Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8741-01EA - Each0093-8741afdd91a4-001f-4919-8ed4-a6099bcbd0a012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8741MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 1 package rows20230630_693da40b-26d4-40d6-87d1-158e256f40ab.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEAvKAREc528aae3-ff51-b9e4-a401-4ef5910e4b432026-01-15Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 074377
application number: ANDA074377
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.693da40b-26d4-40d6-87d1-158e256f40ab2022-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074377
application number: ANDA074377
ndc (product): 0093-8741

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSN693da40b-26d4-40d6-87d1-158e256f40ab11
1362712mexiletine HCl 200 MG Oral CapsulePSN693da40b-26d4-40d6-87d1-158e256f40ab11
1362720mexiletine HCl 250 MG Oral CapsulePSN693da40b-26d4-40d6-87d1-158e256f40ab11
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD693da40b-26d4-40d6-87d1-158e256f40ab11
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCD693da40b-26d4-40d6-87d1-158e256f40ab11
1362720mexiletine hydrochloride 250 MG Oral CapsuleSCD693da40b-26d4-40d6-87d1-158e256f40ab11
1362706mexiletine HCl 150 MG Oral CapsulePSNc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362712mexiletine HCl 200 MG Oral CapsulePSNc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362720mexiletine HCl 250 MG Oral CapsulePSNc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCDc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCDc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362720mexiletine hydrochloride 250 MG Oral CapsuleSCDc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362720mexiletine HCl 250 MG Oral CapsulePSNbb8c0b61-fcb1-4b51-9505-f1670693f00f3
1362720mexiletine hydrochloride 250 MG Oral CapsuleSCDbb8c0b61-fcb1-4b51-9505-f1670693f00f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8741-0100093874101100 CAPSULE in 1 BOTTLE (0093-8741-01) 100 capsule1995-06-050000-00-00NoNoCurrent
0093-8741-990009387419937500 CAPSULE in 1 PAIL (0093-8741-99)37500 capsule30-MAR-23Current