Chlorzoxazone

Product NDC
50090-0316
11-digit product format
500900316
Labeler code
50090
Product ID
50090-0316_197953b4-73c1-4054-a938-8d277f863dfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA089859
Marketing category
ANDA
Marketing start
2011-08-22
Marketing end
0000-00-00
Substance
CHLORZOXAZONE
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct50090-0316IInactivated by FDA2026-08-17
excluded packagepackage50090-031650090-0316-0IInactivated by FDA2026-08-17

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 · 30 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 packagepackage50090-0316-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0316-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0316-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0316-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0316-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0316-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0316-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0316-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0316-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0316-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0316-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0316-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-0316-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-0316-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-0316-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089859-001CHLORZOXAZONECHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089859-001AA

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A089859-001CHLORZOXAZONE500MGTABLET / ORALRS1988-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A089859-001CHLORZOXAZONE500MGTABLET / ORALRS1988-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089859-001CHLORZOXAZONE500MGTABLET / ORALAARS1988-05-04e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A089859-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089859-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089859-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089859-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089859-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089859-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089859-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089859-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089859-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089859-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089859-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089859-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089859-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089859-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089859-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089859-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089859-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089859-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089859-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089859-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089859-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089859-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A089859-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089859-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089859-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089859-001AA13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089859-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089859-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089859-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089859-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089859-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089859-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089859-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A089859-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089859-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089859-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089859-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089859-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089859-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089859-001AA1a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0316-02023-01-30C16284748780-1f386c649-ac51-0266-e053-dadaa90a7c1aChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0316-0Chlorzoxazone7 in 1 BOTTLETABLET714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0316-0EA - Each50090-03169e3f4ff7-8c4d-45ad-8ff3-735cdffe97d712018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0316CHLORZOXAZONE TABLET [A-S MEDICATION SOLUTIONS]14Legacy NDC, 1 package rows20200128_75305abd-a545-401e-8ab7-c9c5edfc91f1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorzoxazoneCHLORZOXAZONEPD-Rx Pharmaceuticals, Inc.8650d342-92df-48d7-9f3d-cdd6f6f4c0e72025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089859
application number: ANDA089859
ChlorzoxazoneCHLORZOXAZONEBryant Ranch Prepack5e6889c9-a091-4622-0a00-ad0fc1830f782024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089859
application number: ANDA089859
ChlorzoxazoneCHLORZOXAZONEActavis Pharma, Inc.2f05e8e2-616f-475b-ac9f-c42e1a5dbe812024-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089859
application number: ANDA089859
ChlorzoxazoneCHLORZOXAZONEA-S Medication Solutions6c418b8f-4a1c-4611-80d5-3a3a7dbca9c82023-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089859
application number: ANDA089859
ChlorzoxazoneCHLORZOXAZONEProficient Rx LP63338935-f3dd-4ef1-bb66-856a83c95f412022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089859
application number: ANDA089859

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN75305abd-a545-401e-8ab7-c9c5edfc91f114
197502chlorzoxazone 500 MG Oral TabletSCD75305abd-a545-401e-8ab7-c9c5edfc91f114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0316-0500900316007 TABLET in 1 BOTTLE (50090-0316-0) 7 tablet2016-06-290000-00-00NoNoCurrent