chlorzoxazone

Product NDC
46672-860
11-digit product format
466720860
Labeler code
46672
Product ID
46672-860_9c6f58aa-cfba-72e1-e053-2995a90ab123
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA207483
Marketing category
ANDA
Marketing start
2016-06-24
Marketing end
0000-00-00
Substance
CHLORZOXAZONE
Active strength
250 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
A207483-001CHLORZOXAZONECHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207483-001AA

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 06:07:402026-07A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-243f01610625f2…
2019-09-15 20:21 UTC2019-09A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A207483-001CHLORZOXAZONE250MGTABLET / ORALRS2016-06-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207483-001CHLORZOXAZONE250MGTABLET / ORALAARS2016-06-24e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207483-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207483-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207483-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207483-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207483-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207483-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207483-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207483-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207483-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207483-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207483-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207483-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207483-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207483-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207483-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207483-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207483-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207483-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207483-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207483-001AA1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207483-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207483-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207483-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207483-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207483-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207483-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207483-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207483-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207483-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207483-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207483-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207483-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207483-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207483-001AA1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46672-860-46EA - Each46672-8600431dc4a-4a46-4a2e-8e58-16c0c9685ccf12019-06-19

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
chlorzoxazoneCHLORZOXAZONESolubiomixc3d40a90-6df8-4b44-bc61-d7655c52bacb2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207483
application number: ANDA207483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-860-0546672086005500 TABLET in 1 BOTTLE, PLASTIC (46672-860-05) 500 tablet2016-06-240000-00-00NoNoCurrent
46672-860-1046672086010100 TABLET in 1 BOTTLE, PLASTIC (46672-860-10) 100 tablet2016-06-240000-00-00NoNoCurrent
46672-860-464667208604660 TABLET in 1 BOTTLE, PLASTIC (46672-860-46) 60 tablet2016-06-240000-00-00NoNoCurrent