Home NDC 0254-2005 Chlorzoxazone
Product NDC 0254-2005
11-digit product format 002542005
Labeler code 0254
Product ID 0254-2005_fdae58ba-f86a-47bc-af18-a80d5cfa1107
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorzoxazone
Dosage form TABLET
Route ORAL
Labeler Endo USA, Inc.
Application ANDA212743
Marketing category ANDA
Marketing start 2020-11-04
Substance CHLORZOXAZONE
Active strength 750 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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212743-001 CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 A212743-002 CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 69 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212743-002 CHLORZOXAZONE 375MG TABLET / ORAL AB 2021-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212743-001 CHLORZOXAZONE 750MG TABLET / ORAL AB 2020-11-02 5aa47cf7b7d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Chlorzoxazone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORZOXAZONE 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0DE420U8G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1088934 Internal RxNorm lookup 1088936 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0254-2005-01 Chlorzoxazone 100 in 1 BOTTLE TABLET 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0254-2005 CHLORZOXAZONE TABLET [ENDO USA, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20250112_7c5a835d-3754-4c25-a0e2-335b8eceb2d2.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0254-2005-01 00254200501 100 TABLET in 1 BOTTLE (0254-2005-01) 100 tablet 2020-11-04 0000-00-00 No No Current