CHLORZOXAZONE

Product NDC
80175-0085
11-digit product format
801750085
Labeler code
80175
Product ID
80175-0085_bd99bd77-520e-5cb2-e053-2995a90a6eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Central Packaging
Application
ANDA212254
Marketing category
ANDA
Marketing start
2019-09-12
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
2022-12-31
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 productproduct80175-0085IInactivated by FDA2026-08-17
excluded packagepackage80175-008580175-0085-9IInactivated 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 · 38 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 packagepackage80175-0085-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80175-0085-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80175-0085-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80175-0085-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80175-0085-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80175-0085-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80175-0085-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage80175-0085-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage80175-0085-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage80175-0085-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage80175-0085-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage80175-0085-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage80175-0085-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage80175-0085-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage80175-0085-91332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage80175-0085-9fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage80175-0085-986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80175-0085-9bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage80175-0085-98dfbde2a14a4…c9ff85d89658…

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
A212254-001CHLORZOXAZONECHLORZOXAZONE500MGTABLET / ORALAA2019-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212254-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-123f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212254-001CHLORZOXAZONE500MGTABLET / ORALAA2019-09-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212254-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212254-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212254-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212254-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212254-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212254-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212254-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212254-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212254-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212254-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212254-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212254-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212254-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212254-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212254-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212254-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212254-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212254-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212254-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212254-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212254-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212254-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A212254-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212254-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212254-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212254-001AA13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212254-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212254-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212254-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212254-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212254-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212254-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212254-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212254-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212254-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212254-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212254-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212254-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212254-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212254-001AA1a50c72e98297…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80175-0085-9CHLORZOXAZONE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0085CHLORZOXAZONE TABLET [CENTRAL PACKAGING]1Legacy NDC, 1 package rows20210307_bccfb7cb-f8af-1a85-e053-2a95a90ad052.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
ChlorzoxazoneCHLORZOXAZONEBryant Ranch Prepack267a0a2a-b818-47d9-9b61-28be172de99a2023-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212254
application number: ANDA212254
ChlorzoxazoneCHLORZOXAZONENovitium Pharma LLC69c87a85-4b6b-405b-9fa5-4c91c0f90c702021-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212254
application number: ANDA212254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSNbccfb7cb-f8af-1a85-e053-2a95a90ad0521
197502chlorzoxazone 500 MG Oral TabletSCDbccfb7cb-f8af-1a85-e053-2a95a90ad0521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80175-0085-98017500850990 TABLET in 1 BOTTLE (80175-0085-9) 90 tablet2019-09-120000-00-00NoNoCurrent