Prescription drug · ANDA
Chlorzoxazone NDC 59651-307
Chlorzoxazone 750 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-307-01 | 59651030701 | 100 TABLET in 1 BOTTLE (59651-307-01)Marketed from Aug 17, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Chlorzoxazone
- Generic name (nonproprietary)
- chlorzoxazone
- Active ingredients
- Chlorzoxazone — 750 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089853
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 59651-307_13956b60-a22d-4ee8-af95-460830ebfbc9SPL ID 13956b60-a22d-4ee8-af95-460830ebfbc9SPL set ID 52d3aa2c-f88f-4de7-b5ae-df8a46e94879RxCUI 197502, 1088934, 1088936UNII H0DE420U8GUPC 0359651307014
- Pharmacologic class
- Muscle Relaxant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459651030701followed by a unit qualifier and the quantityPackage 59651-0307-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 089853
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2009 |
| Chlorzoxazone | Chlorzoxazone 375 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-305 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-306 |
| Chlorzoxazone | Chlorzoxazone 375 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0525 |
| Chlorzoxazone | Chlorzoxazone 750 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0526 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0315 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Proficient Rx LP | 71205-711 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4364 |