Prescription drug · ANDA
Cyclobenzaprine HCL NDC 80425-0018
Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0018-1 | 80425001801 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0018-1)Marketed from May 31, 2017 | |
| 80425-0018-2 | 80425001802 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0018-2)Marketed from May 31, 2017 | |
| 80425-0018-3 | 80425001803 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0018-3)Marketed from May 31, 2017 |
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)
- Cyclobenzaprine HCL
- Generic name (nonproprietary)
- cyclobenzaprine hcl
- Active ingredients
- Cyclobenzaprine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208170
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 80425-0018_2a985a04-15cf-b8b6-e063-6394a90a4231SPL ID 2a985a04-15cf-b8b6-e063-6394a90a4231SPL set ID afcab35f-4ab9-33a4-e053-2a95a90ad529RxCUI 828348UNII 0VE05JYS2P
- 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
N480425001801followed by a unit qualifier and the quantityPackage 80425-0018-01. 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 Section INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208170
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 |
|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 72603-310 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3814 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-265 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2084 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8474 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | HAWAII REPACK, INC. | 85534-0085 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-080 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | HAWAII REPACK, INC. | 85534-0086 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-003 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-010 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-197 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-547 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-714 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-716 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-041 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-065 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1014 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4751 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceutuicals,Inc. | 68071-4655 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0498 |
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