Home NDC 71335-3122 CHLORZOXAZONE
Product NDC 71335-3122
11-digit product format 713353122
Labeler code 71335
Product ID 71335-3122_873dd349-a1c6-40a4-ab75-2fcad8577456
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORZOXAZONE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA210961
Marketing category ANDA
Marketing start 2024-03-21
Substance CHLORZOXAZONE
Active strength 500 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210961-001 CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210961-001 AA
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.
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 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210961-001 CHLORZOXAZONE 500MG TABLET / ORAL AA 2024-01-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CHLORZOXAZONE
Listing expiration 2027-12-31 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# 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 · 2 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 71335-3122-0 71335312200 10 TABLET in 1 BOTTLE (71335-3122-0) 10 tablet 2026-04-13 No No Current 71335-3122-1 71335312201 20 TABLET in 1 BOTTLE (71335-3122-1) 20 tablet 2026-04-13 No No Current 71335-3122-2 71335312202 30 TABLET in 1 BOTTLE (71335-3122-2) 30 tablet 2026-04-13 No No Current 71335-3122-3 71335312203 40 TABLET in 1 BOTTLE (71335-3122-3) 40 tablet 2026-04-13 No No Current 71335-3122-4 71335312204 90 TABLET in 1 BOTTLE (71335-3122-4) 90 tablet 2026-04-13 No No Current 71335-3122-5 71335312205 60 TABLET in 1 BOTTLE (71335-3122-5) 60 tablet 2026-04-13 No No Current 71335-3122-6 71335312206 100 TABLET in 1 BOTTLE (71335-3122-6) 100 tablet 2026-04-13 No No Current 71335-3122-7 71335312207 14 TABLET in 1 BOTTLE (71335-3122-7) 14 tablet 2026-04-13 No No Current 71335-3122-8 71335312208 7 TABLET in 1 BOTTLE (71335-3122-8) 7 tablet 2026-04-13 No No Current 71335-3122-9 71335312209 120 TABLET in 1 BOTTLE (71335-3122-9) 120 tablet 2026-04-13 No No Current