Chlorzoxazone

Product NDC
50090-0315
11-digit product format
500900315
Labeler code
50090
Product ID
50090-0315_961bd335-5552-432f-a0fc-457aac9276f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0315-0Chlorzoxazone30 in 1 BOTTLETABLET3021
50090-0315-1Chlorzoxazone20 in 1 BOTTLETABLET2021
50090-0315-3Chlorzoxazone60 in 1 BOTTLETABLET6021
50090-0315-4Chlorzoxazone40 in 1 BOTTLETABLET4021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0315-0EA - Each50090-0315342d84c7-6af7-4370-82ac-629da454905f12018-09-05
50090-0315-1EA - Each50090-03157f65a994-8b6c-40fb-9a16-461eadf2338612018-09-05
50090-0315-3EA - Each50090-0315469f7a26-8cb1-4371-8a39-481a533eb9ee12018-09-05
50090-0315-4EA - Each50090-0315165d3a1d-70bd-4109-8227-a5b2489199a612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0315CHLORZOXAZONE TABLET [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 4 package rows20230317_6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8.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
ndc (product): 50090-0315
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 TabletPSN6c418b8f-4a1c-4611-80d5-3a3a7dbca9c821
197502chlorzoxazone 500 MG Oral TabletSCD6c418b8f-4a1c-4611-80d5-3a3a7dbca9c821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0315-05009003150030 TABLET in 1 BOTTLE (50090-0315-0) 30 tablet2016-06-290000-00-00NoNoCurrent
50090-0315-15009003150120 TABLET in 1 BOTTLE (50090-0315-1) 20 tablet2016-06-290000-00-00NoNoCurrent
50090-0315-35009003150360 TABLET in 1 BOTTLE (50090-0315-3) 60 tablet2016-06-290000-00-00NoNoCurrent
50090-0315-45009003150440 TABLET in 1 BOTTLE (50090-0315-4) 40 tablet2016-06-290000-00-00NoNoCurrent