Chlorzoxazone

Product NDC
71335-1914
11-digit product format
713351914
Labeler code
71335
Product ID
71335-1914_fc8abd66-24d1-cd1a-e053-6394a90afa7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212254
Marketing category
ANDA
Marketing start
2019-09-12
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
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…

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
267a0a2a-b818-47d9-9b61-28be172de99aAvailable 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
0a48cfb8-244e-463e-aa85-fd9bbbc9190aProduct name220200224
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1914-1Chlorzoxazone20 in 1 BOTTLETABLET20103
71335-1914-2Chlorzoxazone30 in 1 BOTTLETABLET30103
71335-1914-3Chlorzoxazone40 in 1 BOTTLETABLET40103
71335-1914-4Chlorzoxazone90 in 1 BOTTLETABLET90103
71335-1914-5Chlorzoxazone60 in 1 BOTTLETABLET60103
71335-1914-6Chlorzoxazone100 in 1 BOTTLETABLET100103
71335-1914-7Chlorzoxazone14 in 1 BOTTLETABLET14103
71335-1914-8Chlorzoxazone7 in 1 BOTTLETABLET7103
71335-1914-9Chlorzoxazone120 in 1 BOTTLETABLET120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1914-2EA - Each71335-191458c94390-4929-437c-961b-d104887b8e0a12021-11-09
71335-1914-4EA - Each71335-1914c3355ca7-8bbe-4225-adba-81a6cc17cd0012021-11-09
71335-1914-5EA - Each71335-19148e7435e2-5b1a-43f6-b3d1-9cde1462ae5a12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1914CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20230602_267a0a2a-b818-47d9-9b61-28be172de99a.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
ndc (product): 71335-1914
ChlorzoxazoneCHLORZOXAZONENovitium Pharma LLC69c87a85-4b6b-405b-9fa5-4c91c0f90c702021-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212254
application number: ANDA212254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN267a0a2a-b818-47d9-9b61-28be172de99a103
197502chlorzoxazone 500 MG Oral TabletSCD267a0a2a-b818-47d9-9b61-28be172de99a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1914-17133519140120 TABLET in 1 BOTTLE (71335-1914-1) 20 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-27133519140230 TABLET in 1 BOTTLE (71335-1914-2) 30 tablet2021-08-100000-00-00NoNoCurrent
71335-1914-37133519140340 TABLET in 1 BOTTLE (71335-1914-3) 40 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-47133519140490 TABLET in 1 BOTTLE (71335-1914-4) 90 tablet2021-07-140000-00-00NoNoCurrent
71335-1914-57133519140560 TABLET in 1 BOTTLE (71335-1914-5) 60 tablet2021-09-160000-00-00NoNoCurrent
71335-1914-671335191406100 TABLET in 1 BOTTLE (71335-1914-6) 100 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-77133519140714 TABLET in 1 BOTTLE (71335-1914-7) 14 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-8713351914087 TABLET in 1 BOTTLE (71335-1914-8) 7 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-971335191409120 TABLET in 1 BOTTLE (71335-1914-9) 120 tablet2021-10-250000-00-00NoNoCurrent