Prescription drug · ANDA
Chlorzoxazone NDC 55289-633
Chlorzoxazone 500 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-633-10 | 55289063310 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-633-10)Marketed from Aug 31, 2011 | |
| 55289-633-20 | 55289063320 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-633-20)Marketed from Aug 31, 2011 | |
| 55289-633-24 | 55289063324 | 24 TABLET in 1 BOTTLE, PLASTIC (55289-633-24)Marketed from Aug 31, 2011 | |
| 55289-633-28 | 55289063328 | 28 TABLET in 1 BOTTLE, PLASTIC (55289-633-28)Marketed from Aug 31, 2011 | |
| 55289-633-30 | 55289063330 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-633-30)Marketed from Aug 31, 2011 | |
| 55289-633-40 | 55289063340 | 40 TABLET in 1 BOTTLE, PLASTIC (55289-633-40)Marketed from Aug 31, 2011 |
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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089859
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 55289-633_419b15d3-6522-5d1c-e063-6394a90abbd0SPL ID 419b15d3-6522-5d1c-e063-6394a90abbd0SPL set ID 8650d342-92df-48d7-9f3d-cdd6f6f4c0e7RxCUI 197502UNII H0DE420U8GUPC 0355289633280
- 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
N455289063310followed by a unit qualifier and the quantityPackage 55289-0633-10. 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 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 089859
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 | A-S Medication Solutions | 50090-0315 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Proficient Rx LP | 63187-317 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-2520 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1586 |