Home NDC 64980-582 Chlorzoxazone
Product NDC 64980-582
11-digit product format 649800582
Labeler code 64980
Product ID 64980-582_566bef40-8065-4ade-a39e-379504f0c430
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorzoxazone
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA216925
Marketing category ANDA
Marketing start 2023-08-09
Substance CHLORZOXAZONE
Active strength 250 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216925-001 CHLORZOXAZONE CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216925-001 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 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216925-001 CHLORZOXAZONE 250MG TABLET / ORAL AA 2023-08-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Chlorzoxazone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORZOXAZONE 250 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 197501 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 64980-582-06 Chlorzoxazone 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-582 CHLORZOXAZONE TABLET [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 1 package rows 20230830_e0d10d67-9716-450b-b8a9-4e157008864e.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 Sample Exclude flag Status 64980-582-06 64980058206 60 TABLET in 1 BOTTLE (64980-582-06) 60 tablet 2023-08-09 No No Current