Chlorzoxazone

Product NDC
70518-2875
11-digit product format
705182875
Labeler code
70518
Product ID
70518-2875_af5bfe3b-3eb9-38fc-e053-2a95a90a86cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212254
Marketing category
ANDA
Marketing start
2020-09-10
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 productproduct70518-2875DDiscontinued by firm2026-08-17
excluded packagepackage70518-287570518-2875-0DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2875-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2875-0IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2875-0IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2875-0IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2875-0IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2875-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2875-0IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2875-0IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2875-0IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2875-0IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2875-0IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2875-0IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70518-2875-0IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70518-2875-0IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70518-2875-0IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70518-2875-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70518-2875-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70518-2875-0IInactivated by FDAbd6a592717d7…303034d00443…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2875CHLORZOXAZONE TABLET [REMEDYREPACK INC.]1Legacy NDC20200916_6d79875f-5654-4242-82af-a5110ab0fbc9.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2875-07051828750020 TABLET in 1 BOTTLE, PLASTIC (70518-2875-0) 20 tablet2020-09-100000-00-00NoNoCurrent