Home NDC 55289-633 Chlorzoxazone
Product NDC 55289-633
11-digit product format 552890633
Labeler code 55289
Product ID 55289-633_419b15d3-6522-5d1c-e063-6394a90abbd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorzoxazone
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA089859
Marketing category ANDA
Marketing start 2011-08-22
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089859-001 CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089859-001 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.
Product history page 1 of 2 · 42 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 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL RS 1988-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL RS 1988-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 e64feba35796…
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 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 55289-633-10 Chlorzoxazone 10 in 1 BOTTLE, PLASTIC TABLET 10 30 55289-633-20 Chlorzoxazone 20 in 1 BOTTLE, PLASTIC TABLET 20 30 55289-633-24 Chlorzoxazone 24 in 1 BOTTLE, PLASTIC TABLET 24 30 55289-633-28 Chlorzoxazone 28 in 1 BOTTLE, PLASTIC TABLET 28 30 55289-633-30 Chlorzoxazone 30 in 1 BOTTLE, PLASTIC TABLET 30 30 55289-633-40 Chlorzoxazone 40 in 1 BOTTLE, PLASTIC TABLET 40 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-633 CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.] 29 Current NDC, Legacy NDC, 6 package rows 20241006_8650d342-92df-48d7-9f3d-cdd6f6f4c0e7.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 · 5 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 55289-633-10 55289063310 10 TABLET in 1 BOTTLE, PLASTIC (55289-633-10) 10 tablet 2011-08-31 0000-00-00 No No Current 55289-633-20 55289063320 20 TABLET in 1 BOTTLE, PLASTIC (55289-633-20) 20 tablet 2011-08-31 0000-00-00 No No Current 55289-633-24 55289063324 24 TABLET in 1 BOTTLE, PLASTIC (55289-633-24) 24 tablet 2011-08-31 0000-00-00 No No Current 55289-633-28 55289063328 28 TABLET in 1 BOTTLE, PLASTIC (55289-633-28) 28 tablet 2011-08-31 0000-00-00 No No Current 55289-633-30 55289063330 30 TABLET in 1 BOTTLE, PLASTIC (55289-633-30) 30 tablet 2011-08-31 0000-00-00 No No Current 55289-633-40 55289063340 40 TABLET in 1 BOTTLE, PLASTIC (55289-633-40) 40 tablet 2011-08-31 0000-00-00 No No Current