Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 65162-541
Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-541-10 | 65162054110 | 100 TABLET, FILM COATED in 1 BOTTLE (65162-541-10)Marketed from Feb 18, 2010 | |
| 65162-541-11 | 65162054111 | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-541-11)Marketed from Feb 18, 2010 | |
| 65162-541-50 | 65162054150 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-541-50)Marketed from Feb 18, 2010 |
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)
- Cyclobenzaprine Hydrochloride
- Generic name (nonproprietary)
- cyclobenzaprine hydrochloride
- Active ingredients
- Cyclobenzaprine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078218
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 65162-541_df260758-80f8-4668-884c-7fb21600db2eSPL ID df260758-80f8-4668-884c-7fb21600db2eSPL set ID 390151d4-5fcb-46e2-92e6-de184827f43dRxCUI 828320, 828348UNII 0VE05JYS2PUPC 0365162541106, 0365162540109
- 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
N465162054110followed by a unit qualifier and the quantityPackage 65162-0541-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.