CHLORZOXAZONE
- Product NDC
- 85766-283
- 11-digit product format
- 857660283
- Labeler code
- 85766
- Product ID
- 85766-283_5c99ec84-6bd7-e55f-e063-6394a90a5813
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CHLORZOXAZONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA089853
- Marketing category
- ANDA
- Marketing start
- 2020-08-03
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089853-001 | CHLORZOXAZONE | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | |
| A089853-002 | CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | |
| A089853-003 | CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A089853-001 | AA |
| A089853-002 | AB |
| A089853-003 | AB |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089853-002 | CHLORZOXAZONE | 375MG | TABLET / ORAL | AB | 2023-08-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089853-003 | CHLORZOXAZONE | 750MG | TABLET / ORAL | AB | 2023-08-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089853-001 | CHLORZOXAZONE | 500MG | TABLET / ORAL | AA | 1988-05-04 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A089853-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A089853-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A089853-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A089853-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A089853-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A089853-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A089853-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A089853-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A089853-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089853-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089853-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089853-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A089853-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A089853-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A089853-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089853-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089853-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089853-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089853-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089853-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089853-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089853-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089853-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089853-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089853-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089853-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089853-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089853-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089853-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089853-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089853-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089853-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089853-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A089853-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A089853-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A089853-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089853-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089853-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089853-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089853-001 | AA | 1 | 301d65b070ca… |
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 |
|---|---|
| CHLORZOXAZONE | 500 mg/1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CHLORZOXAZONE | CHLORZOXAZONE | REMEDYREPACK INC. | 3f73a1d1-b3ee-4678-bc02-3258ec812127 | 2026-01-29 | Warnings, Adverse reactions | 089853 ANDA089853 |
| CHLORZOXAZONE | CHLORZOXAZONE | Advanced Rx of Tennessee, LLC | 36c1eb43-8840-8d84-e063-6394a90addca | 2025-05-29 | Warnings, Adverse reactions | 089853 ANDA089853 |
| CHLORZOXAZONE | CHLORZOXAZONE | Proficient Rx LP | 0a8ee5fa-f393-4568-81bd-269f9a4cecd6 | 2025-03-01 | Warnings, Adverse reactions | 089853 ANDA089853 |
| Chlorzoxazone | CHLORZOXAZONE | Advanced Rx Pharmacy of Tennessee, LLC | f8ff7293-89b6-b6ee-e053-6394a90a7d39 | 2024-12-31 | Warnings, Adverse reactions | 089853 ANDA089853 |
| CHLORZOXAZONE | CHLORZOXAZONE | Bryant Ranch Prepack | 669afcc1-d587-4dc0-8f6e-99109bcfed36 | 2024-04-03 | Warnings, Adverse reactions | 089853 ANDA089853 |
| CHLORZOXAZONE | CHLORZOXAZONE | Aurobindo Pharma Limited | 52d3aa2c-f88f-4de7-b5ae-df8a46e94879 | 2023-09-05 | Warnings, Adverse reactions | 089853 ANDA089853 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85766-283-01 | 85766028301 | 100 TABLET in 1 BOTTLE (85766-283-01) | 100 tablet | 2026-09-29 | No | No | Current |
| 85766-283-10 | 85766028310 | 10 TABLET in 1 BOTTLE (85766-283-10) | 10 tablet | 2026-09-29 | No | No | Current |
| 85766-283-14 | 85766028314 | 14 TABLET in 1 BOTTLE (85766-283-14) | 14 tablet | 2026-09-29 | No | No | Current |
| 85766-283-20 | 85766028320 | 20 TABLET in 1 BOTTLE (85766-283-20) | 20 tablet | 2026-09-29 | No | No | Current |
| 85766-283-28 | 85766028328 | 28 TABLET in 1 BOTTLE (85766-283-28) | 28 tablet | 2026-09-29 | No | No | Current |
| 85766-283-30 | 85766028330 | 30 TABLET in 1 BOTTLE (85766-283-30) | 30 tablet | 2026-09-29 | No | No | Current |
| 85766-283-60 | 85766028360 | 60 TABLET in 1 BOTTLE (85766-283-60) | 60 tablet | 2026-09-29 | No | No | Current |
| 85766-283-90 | 85766028390 | 90 TABLET in 1 BOTTLE (85766-283-90) | 90 tablet | 2026-09-29 | No | No | Current |