CHLORZOXAZONE
- Product NDC
- 80425-0526
- 11-digit product format
- 804250526
- Labeler code
- 80425
- Product ID
- 80425-0526_36c1e480-6aa2-03e2-e063-6294a90a7280
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CHLORZOXAZONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA089853
- Marketing category
- ANDA
- Marketing start
- 2025-05-29
- Substance
- CHLORZOXAZONE
- Active strength
- 750 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
openFDA Listing Details
- Product ID
- 80425-0526_36c1e480-6aa2-03e2-e063-6294a90a7280
- SPL ID
- 36c1e480-6aa2-03e2-e063-6294a90a7280
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- CHLORZOXAZONE
- Generic name
- CHLORZOXAZONE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2025-05-29
- Marketing category
- ANDA
- Application number
- ANDA089853
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CHLORZOXAZONE | 750 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | H0DE420U8G |
| Rxcui | 1088934, 1088936 |
| Spl Set Id | 36c1eb43-8840-8d84-e063-6394a90addca |
| Manufacturer Name | Advanced Rx of Tennessee, LLC |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 80425-0526-1 | 30 TABLET in 1 BOTTLE (80425-0526-1) | 2025-05-29 | No |
| 80425-0526-2 | 60 TABLET in 1 BOTTLE (80425-0526-2) | 2025-05-29 | No |
| 80425-0526-3 | 90 TABLET in 1 BOTTLE (80425-0526-3) | 2025-05-29 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| H0DE420U8G | CHLORZOXAZONE | 95-25-0 | CHLORZOXAZONE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0526-1 | 80425052601 | 30 TABLET in 1 BOTTLE (80425-0526-1) | 30 tablet | 2025-05-29 | No | No | Historical |
| 80425-0526-2 | 80425052602 | 60 TABLET in 1 BOTTLE (80425-0526-2) | 60 tablet | 2025-05-29 | No | No | Historical |
| 80425-0526-3 | 80425052603 | 90 TABLET in 1 BOTTLE (80425-0526-3) | 90 tablet | 2025-05-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Chlorzoxazone Tablets, USP | Advanced Rx of Tennessee, LLC | 2025-05-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |