Chlorzoxazone

Product NDC
21695-569
11-digit product format
216950569
Labeler code
21695
Product ID
21695-569_48945996-e8b9-462f-b454-3b11fd844a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA089895
Marketing category
ANDA
Marketing start
1988-05-04
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
E
Listing certified through
2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-569IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-07IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-10IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-14IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-20IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-30IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-60IInactivated by FDA2026-08-17
excluded packagepackage21695-56921695-569-90IInactivated 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 3 · 176 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 packagepackage21695-569-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-569-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-569-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-569-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-569-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-569-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-569-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-569-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-569-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-569-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-569-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-569-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-569-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-569-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-569-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-569-30ed331223b511…672a5bd82f5f…

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
A089895-001CHLORZOXAZONECHLORZOXAZONE500MGTABLET / ORAL1988-05-04

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 06:07:402026-07A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089895-001CHLORZOXAZONE500MGTABLET / ORAL1988-05-04e64feba35796…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-569-07Chlorzoxazone7 in 1 BOTTLETABLET72
21695-569-10Chlorzoxazone10 in 1 BOTTLETABLET102
21695-569-14Chlorzoxazone14 in 1 BOTTLETABLET142
21695-569-20Chlorzoxazone20 in 1 BOTTLETABLET202
21695-569-30Chlorzoxazone30 in 1 BOTTLETABLET302
21695-569-60Chlorzoxazone60 in 1 BOTTLETABLET602
21695-569-90Chlorzoxazone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-569-20EA - Each21695-5690bb94784-bb92-4410-b44c-cd3af4d4a09412012-07-24
21695-569-30EA - Each21695-5693a200182-392b-401c-a99e-2ab302e9f9b212012-07-24
21695-569-60EA - Each21695-569a194f197-eff6-4745-af10-5db69662e97e12012-07-24
21695-569-90EA - Each21695-5693b4e5895-3b1c-45b8-bd0b-374f628474e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChlorzoxazoneACTIVE INGREDIENTH0DE420U8GCHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
ChlorzoxazoneACTIVE MOIETYH0DE420U8GCHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-569CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 7 package rows20120223_e1e1c8de-5658-4f94-bf20-f42b59b993c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSNe1e1c8de-5658-4f94-bf20-f42b59b993c52
197502chlorzoxazone 500 MG Oral TabletSCDe1e1c8de-5658-4f94-bf20-f42b59b993c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-569-07216950569077 in 1 BOTTLEHistorical
21695-569-102169505691010 in 1 BOTTLEHistorical
21695-569-142169505691414 in 1 BOTTLEHistorical
21695-569-202169505692020 in 1 BOTTLEHistorical
21695-569-302169505693030 in 1 BOTTLEHistorical
21695-569-602169505696060 in 1 BOTTLEHistorical
21695-569-902169505699090 in 1 BOTTLEHistorical