Chlorzoxazone

Product NDC
53002-5760
11-digit product format
530025760
Labeler code
53002
Product ID
53002-5760_cb876cd6-480a-44ee-85d4-d8875d4fe4a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-5760IInactivated by FDA2026-08-17
excluded packagepackage53002-576053002-5760-1IInactivated by FDA2026-08-17
excluded packagepackage53002-576053002-5760-2IInactivated by FDA2026-08-17
excluded packagepackage53002-576053002-5760-3IInactivated by FDA2026-08-17
excluded packagepackage53002-576053002-5760-5IInactivated 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 · 55 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-5760-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-5760-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-5760-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-5760-5IInactivated by FDAd630ba8d3edf…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 packagepackage53002-5760-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-5760-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-5760-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-5760-5IInactivated 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 packagepackage53002-5760-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-5760-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-5760-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-5760-5IInactivated 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 packagepackage53002-5760-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-5760-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-5760-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-5760-5IInactivated 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 packagepackage53002-5760-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-5760-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-5760-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-5760-5IInactivated 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 packagepackage53002-5760-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-5760-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-5760-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-5760-5IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-5760-5UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-5760-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-5760-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-5760-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-5760-5UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-5760-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-5760-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-5760-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-5760-5UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-5760-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-5760-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-5760-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-5760-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-5760-5IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-5760-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-5760-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-5760-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-5760-5IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-5760-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-5760-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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, Related label table
NDCEffectiveRelated label
53002-5760-12025-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22025-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32025-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52025-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12023-06-07Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22023-06-07Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32023-06-07Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52023-06-07Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12023-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22023-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32023-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52023-01-30Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12020-12-17Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22020-12-17Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32020-12-17Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52020-12-17Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12020-01-31Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22020-01-31Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32020-01-31Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52020-01-31Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5760-1Chlorzoxazone10 in 1 BOTTLETABLET105
53002-5760-2Chlorzoxazone20 in 1 BOTTLETABLET205
53002-5760-3Chlorzoxazone30 in 1 BOTTLETABLET305
53002-5760-5Chlorzoxazone15 in 1 BOTTLETABLET155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5760CHLORZOXAZONE TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20230609_3c3c0279-a570-4ded-9f52-5ef345a6753b.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 TabletPSN3c3c0279-a570-4ded-9f52-5ef345a6753b5
197502chlorzoxazone 500 MG Oral TabletSCD3c3c0279-a570-4ded-9f52-5ef345a6753b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5760-15300257600110 TABLET in 1 BOTTLE (53002-5760-1) 10 tablet2018-10-010000-00-00NoNoCurrent
53002-5760-25300257600220 TABLET in 1 BOTTLE (53002-5760-2) 20 tablet2018-10-010000-00-00NoNoCurrent
53002-5760-35300257600330 TABLET in 1 BOTTLE (53002-5760-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-5760-55300257600515 TABLET in 1 BOTTLE (53002-5760-5) 15 tablet2018-10-010000-00-00NoNoCurrent