Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 55154-0190
Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-0190-0 | 55154019000 | 10 BLISTER PACK in 1 BAG (55154-0190-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 10, 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)
- Cyclobenzaprine Hydrochloride
- Generic name (nonproprietary)
- cyclobenzaprine hydrochloride
- Active ingredients
- Cyclobenzaprine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078643
- Marketing start
- Marketing end
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 55154-0190_175bc564-177b-4752-9bcf-99347bfa2f78SPL ID 175bc564-177b-4752-9bcf-99347bfa2f78SPL set ID df902d94-9d2b-4139-aebb-3eb6b8b8cd54RxCUI 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
N455154019000followed by a unit qualifier and the quantityPackage 55154-0190-00. 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 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, USP should be used only for short periods (up to two or three 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 of short duration a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078643
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 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2110 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-172 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-191 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-190 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3764 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Medsource Pharmaceuticals | 45865-244 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-008 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8167 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2678 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2156 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-678 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8221 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7400 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3474 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7401 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-783 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-782 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2659 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1893 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1893 |
Showing 20 of 22.