Prescription drug · ANDA
Chlorzoxazone NDC 80425-0315
Chlorzoxazone 500 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0315-1 | 80425031501 | 30 TABLET in 1 BOTTLE (80425-0315-1)Marketed from Apr 10, 2023 | |
| 80425-0315-2 | 80425031502 | 60 TABLET in 1 BOTTLE (80425-0315-2)Marketed from Apr 10, 2023 | |
| 80425-0315-3 | 80425031503 | 90 TABLET in 1 BOTTLE (80425-0315-3)Marketed from Apr 10, 2023 |
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 Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0315_2a9bf621-afbe-7627-e063-6294a90a77a9SPL ID 2a9bf621-afbe-7627-e063-6294a90a77a9SPL set ID f8ff7293-89b6-b6ee-e053-6394a90a7d39RxCUI 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
N480425031501followed by a unit qualifier and the quantityPackage 80425-0315-01. 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 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 80425-0315
- What is NDC 80425-0315?
- 80425-0315 is the product NDC for Chlorzoxazone, Chlorzoxazone 500 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy 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 Pharmacy 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 | Camber Pharmaceuticals, Inc. | 31722-974 | 31722-0974-0131722-0974-0531722-0974-10+2 more |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0507 | 80425-0507-0180425-0507-0280425-0507-03 |
| Chlorzoxazone | Chlorzoxazone 250 mg/1 | TabletOral | Lifsa Drugs LLC | 72336-225 | 72336-0225-60 |
| 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 375 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-305 | 59651-0305-01 |
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 | Advanced Rx of Tennessee, LLC | 80425-0525 |
| Chlorzoxazone | Chlorzoxazone 750 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0526 |
| Chlorzoxazone | Chlorzoxazone 375 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-305 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-306 |
| Chlorzoxazone | Chlorzoxazone 750 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-307 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | Proficient Rx LP | 71205-711 |
| Chlorzoxazone | Chlorzoxazone 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4364 |