Chlorzoxazone

Product NDC
63629-1586
11-digit product format
636291586
Labeler code
63629
Product ID
63629-1586_8f1a738f-23de-466c-83ee-f6f2ddd62799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089859
Marketing category
ANDA
Marketing start
2011-08-22
Substance
CHLORZOXAZONE
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorzoxazone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORZOXAZONE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0DE420U8GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197502Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e6889c9-a091-4622-0a00-ad0fc1830f78Available on FDA.report

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
63629-1586-1Chlorzoxazone20 in 1 BOTTLETABLET209
63629-1586-2Chlorzoxazone30 in 1 BOTTLETABLET309
63629-1586-3Chlorzoxazone40 in 1 BOTTLETABLET409
63629-1586-4Chlorzoxazone90 in 1 BOTTLETABLET909
63629-1586-5Chlorzoxazone60 in 1 BOTTLETABLET609
63629-1586-6Chlorzoxazone100 in 1 BOTTLETABLET1009
63629-1586-7Chlorzoxazone14 in 1 BOTTLETABLET149
63629-1586-8Chlorzoxazone7 in 1 BOTTLETABLET79
63629-1586-9Chlorzoxazone120 in 1 BOTTLETABLET1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1586-1EA - Each63629-1586727023cb-6cc9-47e7-b435-19082594144512012-07-24
63629-1586-2EA - Each63629-1586bc3b4191-a948-4586-acc3-f7a1bf3d038812012-07-24
63629-1586-3EA - Each63629-1586dd0358a4-ef2e-4754-b3e5-c6548c0755aa12012-07-24
63629-1586-4EA - Each63629-1586455f31f3-da7e-488d-bcf8-1122c31b4cd512012-07-24
63629-1586-5EA - Each63629-1586ba553d15-af5a-434f-ac99-7c0167261d8c12012-07-24
63629-1586-6EA - Each63629-1586dd2e66b1-f4f4-4e49-8da0-70f2c38187c512012-07-24
63629-1586-7EA - Each63629-1586a6b44ee0-e6d1-4597-a5e4-fcff5b3295c812015-02-02
63629-1586-8EA - Each63629-1586bda14c1c-d61b-4db9-bdaa-1cb76e286f6b12015-10-02
63629-1586-9EA - Each63629-1586de34d0b8-0a70-458a-b474-1f311ee8768012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORZOXAZONEACTIVE INGREDIENTH0DE420U8GCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
CHLORZOXAZONEACTIVE MOIETYH0DE420U8GCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1586CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20241012_5e6889c9-a091-4622-0a00-ad0fc1830f78.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
ndc (product): 63629-1586
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 TabletPSN5e6889c9-a091-4622-0a00-ad0fc1830f789
197502chlorzoxazone 500 MG Oral TabletSCD5e6889c9-a091-4622-0a00-ad0fc1830f789

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1586-16362915860120 TABLET in 1 BOTTLE (63629-1586-1) 20 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-26362915860230 TABLET in 1 BOTTLE (63629-1586-2) 30 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-36362915860340 TABLET in 1 BOTTLE (63629-1586-3) 40 tablet2012-10-220000-00-00NoNoCurrent
63629-1586-46362915860490 TABLET in 1 BOTTLE (63629-1586-4) 90 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-56362915860560 TABLET in 1 BOTTLE (63629-1586-5) 60 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-663629158606100 TABLET in 1 BOTTLE (63629-1586-6) 100 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-76362915860714 TABLET in 1 BOTTLE (63629-1586-7) 14 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-8636291586087 TABLET in 1 BOTTLE (63629-1586-8) 7 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-963629158609120 TABLET in 1 BOTTLE (63629-1586-9) 120 tablet2012-07-180000-00-00NoNoCurrent