Prescription drug · ANDA
Chlorzoxazone NDC 80425-0507
Chlorzoxazone 500 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0507-1 | 80425050701 | 30 TABLET in 1 BOTTLE (80425-0507-1)Marketed from Mar 20, 2025 | |
| 80425-0507-2 | 80425050702 | 60 TABLET in 1 BOTTLE (80425-0507-2)Marketed from Mar 20, 2025 | |
| 80425-0507-3 | 80425050703 | 90 TABLET in 1 BOTTLE (80425-0507-3)Marketed from Mar 20, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213126
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 80425-0507_30c9d90b-eba6-17be-e063-6394a90a8408SPL ID 30c9d90b-eba6-17be-e063-6394a90a8408SPL set ID 30c9b3ce-198d-0c16-e063-6394a90a857dRxCUI 197502UNII H0DE420U8G
- 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
N480425050701followed by a unit qualifier and the quantityPackage 80425-0507-01. 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.
About NDC 80425-0507
- What is NDC 80425-0507?
- 80425-0507 is the product NDC for Chlorzoxazone, Chlorzoxazone 500 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorzoxazone.
- What is the active ingredient?
- Chlorzoxazone.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlorzoxazone?
- 32 other product NDCs are listed under this name. See all Chlorzoxazone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlorzoxazone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chlorzoxazone | Chlorzoxazone 250 mg/1 | TabletOral | Happy Robin, LLC | 87127-801 | 87127-0801-60 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4364 | 70518-4364-0070518-4364-01 |
| Chlorzoxazone | Chlorzoxazone 375 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0525 | 80425-0525-0180425-0525-0280425-0525-03 |
| Chlorzoxazone | Chlorzoxazone 750 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0526 | 80425-0526-0180425-0526-0280425-0526-03 |
| Chlorzoxazone | Chlorzoxazone 250 mg/1 | TabletOral | Lifsa Drugs LLC | 72336-225 | 72336-0225-60 |
| Chlorzoxazone | Chlorzoxazone 250 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-974 | 31722-0974-0131722-0974-0531722-0974-10+2 more |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3122 | 71335-3122-0071335-3122-0171335-3122-02+7 more |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Cintex Services, LLC | 24470-940 | 24470-0940-1024470-0940-50 |
| Chlorzoxazone | Chlorzoxazone 750 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-307 | 59651-0307-01 |
| Chlorzoxazone | Chlorzoxazone 375 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-305 | 59651-0305-01 |
Other NDCs under ANDA 213126
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 | 71335-2433 |
| Chlorzoxazone | Chlorzoxazone 750 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-727 |
| Chlorzoxazone | Chlorzoxazone 375 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-725 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-726 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7504 |