chlorzoxazone

Product NDC
68462-724
Requested package NDC
68462-724-01
11-digit product format
684620724
Labeler code
68462
Product ID
68462-724_31777bf1-9074-4232-b32f-3e675a68f51d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA212185
Marketing category
ANDA
Marketing start
2020-05-26
Marketing end
2022-07-01
Substance
CHLORZOXAZONE
Active strength
375 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68462-72468462-724-01DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212185-001CHLORZOXAZONECHLORZOXAZONE375MGTABLET / ORAL2020-05-26
A212185-002CHLORZOXAZONECHLORZOXAZONE750MGTABLET / ORAL2020-05-26

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212185-001CHLORZOXAZONE375MGTABLET / ORAL2020-05-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212185-002CHLORZOXAZONE750MGTABLET / ORAL2020-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212185-001CHLORZOXAZONE375MGTABLET / ORALAB2020-05-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212185-002CHLORZOXAZONE750MGTABLET / ORALAB2020-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212185-001CHLORZOXAZONE375MGTABLET / ORALAB2020-05-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212185-002CHLORZOXAZONE750MGTABLET / ORALAB2020-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212185-001CHLORZOXAZONE375MGTABLET / ORALAB2020-05-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212185-002CHLORZOXAZONE750MGTABLET / ORALAB2020-05-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212185-001CHLORZOXAZONE375MGTABLET / ORALAB2020-05-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212185-002CHLORZOXAZONE750MGTABLET / ORALAB2020-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212185-001CHLORZOXAZONE375MGTABLET / ORALAB2020-05-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A212185-002CHLORZOXAZONE750MGTABLET / ORALAB2020-05-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212185-001CHLORZOXAZONE375MGTABLET / ORALAB2020-05-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212185-002CHLORZOXAZONE750MGTABLET / ORALAB2020-05-2687673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212185-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212185-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212185-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212185-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212185-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212185-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212185-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212185-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212185-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212185-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212185-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212185-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212185-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212185-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212185-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212185-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212185-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212185-002AB1c0c555d07b60…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-724-01EA - Each68462-724cc603870-57bc-4d3d-abb0-52fbc2c16e0c12020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-724-0168462072401100 TABLET in 1 BOTTLE, PLASTIC (68462-724-01) 100 tablet2020-05-262022-07-01NoNoCurrent