Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 61919-261
Cyclobenzaprine hydrochloride 7.5 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-261-15 | 61919026115 | 15 TABLET, FILM COATED in 1 BOTTLE (61919-261-15)Marketed from Aug 16, 2019 | |
| 61919-261-82 | 61919026182 | 180 TABLET, FILM COATED in 1 BOTTLE (61919-261-82)Marketed from Aug 16, 2019 |
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 — 7.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078722
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 61919-261_5a0b2979-0c86-102a-e063-6294a90a434aSPL ID 5a0b2979-0c86-102a-e063-6294a90a434aSPL set ID 903e3a5a-7c58-b70d-e053-2a95a90a6f9dRxCUI 828299UNII 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
N461919026115followed by a unit qualifier and the quantityPackage 61919-0261-15. 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.
Other NDCs under ANDA 078722
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 7.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-590 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1848 |
| Cyclobenzaprine HCL | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1001 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-010 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | SA3, LLC | 69420-1001 |
| Cyclobenzaprine HCL | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0078 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0096 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-239 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-9967 |