Home NDC 0591-2520-05 Chlorzoxazone
Product NDC 0591-2520
Requested package NDC 0591-2520-05
11-digit product format 005912520
Labeler code 0591
Product ID 0591-2520_5d8c1717-9bf1-4f71-9718-9ca4f718038a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorzoxazone
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A089859-001 CHLORZOXAZONE 500MG TABLET / ORAL AA RS 1988-05-04 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-2520-01 Chlorzoxazone 100 in 1 BOTTLE, PLASTIC TABLET 100 15 0591-2520-05 Chlorzoxazone 500 in 1 BOTTLE, PLASTIC TABLET 500 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3135 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 CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 7 CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP] 3 CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [DIRECT RX] 2 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [DIRECT RX] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [DIRECT RX] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [DIRECT RX] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [DIRECT RX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [DIRECT RX] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [DIRECT RX] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [DIRECT RX] 2 CHLORZOXAZONE ACTIVE INGREDIENT H0DE420U8G CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 CHLORZOXAZONE ACTIVE MOIETY H0DE420U8G CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLORZOXAZONE TABLET [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2520 CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20240925_2f05e8e2-616f-475b-ac9f-c42e1a5dbe81.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 Marketing end Sample Exclude flag Status 0591-2520-05 00591252005 500 TABLET in 1 BOTTLE, PLASTIC (0591-2520-05) 500 tablet 2011-08-22 0000-00-00 No No Current