FDA.reportPublic FDA data

Mexiletine Hydrochloride

Product NDC
33342-556
Requested package NDC
33342-556-11
11-digit product format
333420556
Labeler code
33342
Product ID
33342-556_a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA219987
Marketing category
ANDA
Marketing start
2026-03-23
Substance
MEXILETINE HYDROCHLORIDE
Active strength
200 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 1.

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
A219987-001MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB2026-03-23
A219987-002MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB2026-03-23
A219987-003MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALAB2026-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219987-001AB
A219987-002AB
A219987-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219987-001MEXILETINE HYDROCHLORIDE150MGCAPSULE / ORALAB2026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219987-002MEXILETINE HYDROCHLORIDE200MGCAPSULE / ORALAB2026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219987-003MEXILETINE HYDROCHLORIDE250MGCAPSULE / ORALAB2026-03-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219987-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219987-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219987-003AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEXILETINE HYDROCHLORIDE200 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
a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1Available 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
33342-556-11Mexiletine Hydrochloride100 in 1 CONTAINERCAPSULE1001
33342-556-12Mexiletine Hydrochloride10 in 1 BLISTER PACKCAPSULE101
33342-556-12Mexiletine Hydrochloride10 in 1 CARTONCAPSULE101

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEMacleods Pharmaceuticals Limiteda61a07f6-0b48-4dcd-ad42-5d90f6e69ab12026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219987
application number: ANDA219987
ndc (package): 33342-556-11
ndc (product): 33342-556
ndc11 (package): 33342055611

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSNa61a07f6-0b48-4dcd-ad42-5d90f6e69ab11
1362712mexiletine HCl 200 MG Oral CapsulePSNa61a07f6-0b48-4dcd-ad42-5d90f6e69ab11
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCDa61a07f6-0b48-4dcd-ad42-5d90f6e69ab11
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCDa61a07f6-0b48-4dcd-ad42-5d90f6e69ab11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-556-1133342055611100 CAPSULE in 1 CONTAINER (33342-556-11) 100 capsule2026-03-23NoNoCurrent