chlorzoxazone

Product NDC
46672-117
11-digit product format
466720117
Labeler code
46672
Product ID
46672-117_9c56a823-bf66-3005-e053-2a95a90a22e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040861
Marketing category
ANDA
Marketing start
2010-06-01
Marketing end
0000-00-00
Substance
CHLORZOXAZONE
Active strength
750 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040861-001CHLORZOXAZONECHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01
A040861-002CHLORZOXAZONECHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040861-001AB
A040861-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040861-001CHLORZOXAZONE375MGTABLET / ORAL2010-06-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040861-002CHLORZOXAZONE750MGTABLET / ORALRS2010-06-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040861-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040861-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040861-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040861-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040861-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040861-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040861-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040861-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040861-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040861-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040861-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040861-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040861-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040861-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A040861-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040861-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040861-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040861-002AB1782e0a99824c…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORZOXAZONEACTIVE INGREDIENTH0DE420U8GCHLORZOXAZONE TABLET [MIKART INC.]2
CHLORZOXAZONEACTIVE MOIETYH0DE420U8GCHLORZOXAZONE TABLET [MIKART INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORZOXAZONE TABLET [MIKART INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORZOXAZONE TABLET [MIKART INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CHLORZOXAZONE TABLET [MIKART INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CHLORZOXAZONE TABLET [MIKART INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORZOXAZONE TABLET [MIKART INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORZOXAZONE TABLET [MIKART INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORZOXAZONE TABLET [MIKART INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-117-1046672011710100 TABLET in 1 BOTTLE (46672-117-10) 100 tablet2010-06-010000-00-00NoNoCurrent
46672-117-5046672011750500 TABLET in 1 BOTTLE (46672-117-50) 500 tablet2010-06-010000-00-00NoNoCurrent