Home NDC 80425-0507 CHLORZOXAZONE
Product NDC 80425-0507
11-digit product format 804250507
Labeler code 80425
Product ID 80425-0507_30c9d90b-eba6-17be-e063-6394a90a8408
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORZOXAZONE
Dosage form TABLET
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA213126
Marketing category ANDA
Marketing start 2025-03-20
Substance CHLORZOXAZONE
Active strength 500 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213126-001 CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 A213126-002 CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET / ORAL AA 2022-04-05 A213126-003 CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 93 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 2026-08-18 06:07:40 2026-07 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AA 2022-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AA 2022-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AA 2022-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213126-002 CHLORZOXAZONE 500MG TABLET / ORAL AB 2022-04-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213126-003 CHLORZOXAZONE 750MG TABLET / ORAL AB 2022-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213126-001 CHLORZOXAZONE 375MG TABLET / ORAL AB 2022-04-05 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 93 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 500 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197502 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 80425-0507-1 CHLORZOXAZONE 30 in 1 BOTTLE TABLET 30 1 80425-0507-2 CHLORZOXAZONE 60 in 1 BOTTLE TABLET 60 1 80425-0507-3 CHLORZOXAZONE 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0507 CHLORZOXAZONE TABLET [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 3 package rows 20250322_30c9b3ce-198d-0c16-e063-6394a90a857d.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0507-1 80425050701 30 TABLET in 1 BOTTLE (80425-0507-1) 30 tablet 2025-03-20 No No Current 80425-0507-2 80425050702 60 TABLET in 1 BOTTLE (80425-0507-2) 60 tablet 2025-03-20 No No Current 80425-0507-3 80425050703 90 TABLET in 1 BOTTLE (80425-0507-3) 90 tablet 2025-03-20 No No Current