Chlorzoxazone

Product NDC
51862-340
11-digit product format
518620340
Labeler code
51862
Product ID
51862-340_31651349-e6e3-4ac1-a506-539961b60e3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma
Application
ANDA211849
Marketing category
ANDA
Marketing start
2020-07-31
Marketing end
2022-10-31
Substance
CHLORZOXAZONE
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
excluded productproduct51862-340DDiscontinued by firm2026-08-03
excluded packagepackage51862-34051862-340-01DDiscontinued by firm2026-08-03

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 · 24 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-340-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-340-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-340-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-340-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-340-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-340-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-340-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-340-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-340-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-340-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-340-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51862-340-01557ba5c1ecfa…9c80585c8c6e…

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
A211849-001CHLORZOXAZONECHLORZOXAZONE375MGTABLET / ORALAB2020-07-21
A211849-002CHLORZOXAZONECHLORZOXAZONE500MGTABLET / ORALAA2020-07-21
A211849-003CHLORZOXAZONECHLORZOXAZONE750MGTABLET / ORALAB2020-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211849-001AB
A211849-002AA
A211849-003AB

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211849-002CHLORZOXAZONE500MGTABLET / ORALAA2020-07-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211849-003CHLORZOXAZONE750MGTABLET / ORALAB2020-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211849-001CHLORZOXAZONE375MGTABLET / ORALAB2020-07-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211849-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211849-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211849-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211849-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211849-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211849-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211849-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211849-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211849-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211849-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211849-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211849-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211849-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211849-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211849-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211849-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211849-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211849-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211849-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211849-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211849-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211849-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211849-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211849-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211849-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211849-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211849-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211849-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211849-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211849-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211849-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211849-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211849-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211849-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211849-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211849-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211849-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211849-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211849-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211849-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a7ba9d15-162f-2741-f0fc-3516be5e88bdProduct name720250114
cbf4a4f8-16cb-4546-a0cc-fd91bbe774f2Product name220240223
0a48cfb8-244e-463e-aa85-fd9bbbc9190aProduct name220200224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-340-01Chlorzoxazone100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-340-01EA - Each51862-340c979983e-e2af-47e4-8747-cdabfffeef3012020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-340CHLORZOXAZONE TABLET [MAYNE PHARMA COMMERCIAL LLC]5Legacy NDC, 1 package rows20230707_5238c99e-d36e-4376-ab05-ca2535213d58.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorzoxazoneCHLORZOXAZONEMayne Pharma Commercial LLC5238c99e-d36e-4376-ab05-ca2535213d582023-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211849
application number: ANDA211849
ndc (product): 51862-340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088934chlorzoxazone 375 MG Oral TabletPSN5238c99e-d36e-4376-ab05-ca2535213d585
197502chlorzoxazone 500 MG Oral TabletPSN5238c99e-d36e-4376-ab05-ca2535213d585
1088936chlorzoxazone 750 MG Oral TabletPSN5238c99e-d36e-4376-ab05-ca2535213d585
1088934chlorzoxazone 375 MG Oral TabletSCD5238c99e-d36e-4376-ab05-ca2535213d585
197502chlorzoxazone 500 MG Oral TabletSCD5238c99e-d36e-4376-ab05-ca2535213d585
1088936chlorzoxazone 750 MG Oral TabletSCD5238c99e-d36e-4376-ab05-ca2535213d585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-340-0151862034001100 TABLET in 1 BOTTLE (51862-340-01) 100 tablet2020-07-312022-10-31NoNoCurrent