CHLORZOXAZONE

Product NDC
24470-923
11-digit product format
244700923
Labeler code
24470
Product ID
24470-923_fc5f1728-0a66-bbb7-e053-6394a90a73e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Cintex Services, LLC
Application
ANDA215158
Marketing category
ANDA
Marketing start
2021-09-23
Substance
CHLORZOXAZONE
Active strength
250 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
A215158-001CHLORZOXAZONECHLORZOXAZONE250MGTABLET / ORALAA2021-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215158-001AA

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 06:07:402026-07A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215158-001CHLORZOXAZONE250MGTABLET / ORALAA2021-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215158-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215158-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215158-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215158-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215158-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215158-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215158-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215158-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215158-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215158-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215158-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215158-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215158-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215158-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215158-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215158-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215158-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215158-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215158-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215158-001AA1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215158-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215158-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215158-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215158-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215158-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215158-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215158-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215158-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A215158-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215158-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215158-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215158-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215158-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215158-001AA1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215158-001CGT2022-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215158-001CGT2022-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215158-001CGT2022-03-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215158-001CGT2022-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215158-001CGT2022-03-29782e0a99824c…
2023-01-26 05:58 UTC2023-01A215158-001CGT2022-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215158-001CGT2022-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215158-001CGT2022-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215158-001CGT2022-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215158-001CGT2022-03-29cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORZOXAZONE250 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
197501Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c95f39c4-0c11-966a-e053-2a95a90a2c18Available 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
24470-923-10CHLORZOXAZONE100 in 1 BOTTLETABLET1005
24470-923-60CHLORZOXAZONE60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-923-60EA - Each24470-923734b5794-9f99-4ead-99de-64c7effb677912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-923CHLORZOXAZONE TABLET [CINTEX SERVICES, LLC]5Current NDC, Legacy NDC, 2 package rows20230524_c95f39c4-0c11-966a-e053-2a95a90a2c18.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
CHLORZOXAZONECHLORZOXAZONEHappy Robin, LLC3f90c7bc-118f-4371-e063-6394a90a279a2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215158
application number: ANDA215158
CHLORZOXAZONECHLORZOXAZONECintex Services, LLCc95f39c4-0c11-966a-e053-2a95a90a2c182023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215158
application number: ANDA215158
ndc (product): 24470-923

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197501chlorzoxazone 250 MG Oral TabletPSNc95f39c4-0c11-966a-e053-2a95a90a2c185
197501chlorzoxazone 250 MG Oral TabletSCDc95f39c4-0c11-966a-e053-2a95a90a2c185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24470-923-1024470092310100 TABLET in 1 BOTTLE (24470-923-10) 100 tablet2021-09-230000-00-00NoNoCurrent
24470-923-602447009236060 TABLET in 1 BOTTLE (24470-923-60) 60 tablet2021-09-230000-00-00NoNoCurrent